Osteoarthritis

VICTORIA, B.C. – Individuals who have physically demanding occupations are at increased risk for osteoarthritis, even in this era of protective measures and equipment, a population-based study has shown.

In this study of a random sample of 88,202 noninstitutionalized U.S. adults, almost one in five reported having physician-diagnosed osteoarthritis (OA), Dr. Chengwei Wang reported in a poster session at the annual meeting of the Canadian Rheumatology Association.

Photo ftwitty/iStockphoto.com

After adjustment for age, sex, ethnicity, and obesity, participants in physically demanding jobs such as building maintenance, health care support, and construction had significantly elevated risks of OA relative to their counterparts in computer and mathematical occupations (the group used for comparison because it had the lowest OA rate). The risk was increased to the greatest extent, essentially doubled, for those in military-specific occupations.

The risk of OA was significantly elevated for participants who were in office and administrative support occupations (relative risk, 1.24); sales and related occupations (1.28); building and grounds cleaning and maintenance (1.37); transportation and material moving (1.38); food preparation and serving (1.41); production (1.47); protective services (1.51); construction and extraction (1.51); health care support (1.54); installation, maintenance, and repair (1.54); and military-specific occupations (2.04).

These findings come from adjusted analyses of data from the U.S. National Health Interview Survey for the years 2005 through 2009 that used participants in computer and mathematical occupations as the reference group. Overall, 19.5% of the sample reported having physician-diagnosed OA.

"Doctors should know that people working in these occupations have a risk factor that plays an important role in developing osteoarthritis," Dr. Wang said in an interview. "I don’t think they need to change occupations. But doctors may want to tell patients to use some preventive measures when they work in these occupations other than to just prescribe medications" for musculoskeletal symptoms, she said.

"We need more-detailed studies to determine what kinds of factors in these occupations play a role in the development of this disease," such as various biomechanical factors, added Dr. Wang, a statistician at Nassau University Medical Center in East Meadow, N.Y. Additionally, the role of duration of exposure requires further investigation.

Such research could eventually help inform the redesign of workplaces and work practices to minimize risk, she said. For example, "occupational therapists and physical medicine and rehabilitation specialists could develop facilities to help protect workers in these occupations further," Dr. Wang suggested.

Dr. Wang said that she and her coauthors had no relevant financial disclosures.

VICTORIA, B.C. – Individuals who have physically demanding occupations are at increased risk for osteoarthritis, even in this era of protective measures and equipment, a population-based study has shown.

In this study of a random sample of 88,202 noninstitutionalized U.S. adults, almost one in five reported having physician-diagnosed osteoarthritis (OA), Dr. Chengwei Wang reported in a poster session at the annual meeting of the Canadian Rheumatology Association.

Photo ftwitty/iStockphoto.com

After adjustment for age, sex, ethnicity, and obesity, participants in physically demanding jobs such as building maintenance, health care support, and construction had significantly elevated risks of OA relative to their counterparts in computer and mathematical occupations (the group used for comparison because it had the lowest OA rate). The risk was increased to the greatest extent, essentially doubled, for those in military-specific occupations.

The risk of OA was significantly elevated for participants who were in office and administrative support occupations (relative risk, 1.24); sales and related occupations (1.28); building and grounds cleaning and maintenance (1.37); transportation and material moving (1.38); food preparation and serving (1.41); production (1.47); protective services (1.51); construction and extraction (1.51); health care support (1.54); installation, maintenance, and repair (1.54); and military-specific occupations (2.04).

These findings come from adjusted analyses of data from the U.S. National Health Interview Survey for the years 2005 through 2009 that used participants in computer and mathematical occupations as the reference group. Overall, 19.5% of the sample reported having physician-diagnosed OA.

"Doctors should know that people working in these occupations have a risk factor that plays an important role in developing osteoarthritis," Dr. Wang said in an interview. "I don’t think they need to change occupations. But doctors may want to tell patients to use some preventive measures when they work in these occupations other than to just prescribe medications" for musculoskeletal symptoms, she said.

"We need more-detailed studies to determine what kinds of factors in these occupations play a role in the development of this disease," such as various biomechanical factors, added Dr. Wang, a statistician at Nassau University Medical Center in East Meadow, N.Y. Additionally, the role of duration of exposure requires further investigation.

Such research could eventually help inform the redesign of workplaces and work practices to minimize risk, she said. For example, "occupational therapists and physical medicine and rehabilitation specialists could develop facilities to help protect workers in these occupations further," Dr. Wang suggested.

Dr. Wang said that she and her coauthors had no relevant financial disclosures.

VICTORIA, B.C. – Individuals who have physically demanding occupations are at increased risk for osteoarthritis, even in this era of protective measures and equipment, a population-based study has shown.

In this study of a random sample of 88,202 noninstitutionalized U.S. adults, almost one in five reported having physician-diagnosed osteoarthritis (OA), Dr. Chengwei Wang reported in a poster session at the annual meeting of the Canadian Rheumatology Association.

Photo ftwitty/iStockphoto.com

After adjustment for age, sex, ethnicity, and obesity, participants in physically demanding jobs such as building maintenance, health care support, and construction had significantly elevated risks of OA relative to their counterparts in computer and mathematical occupations (the group used for comparison because it had the lowest OA rate). The risk was increased to the greatest extent, essentially doubled, for those in military-specific occupations.

The risk of OA was significantly elevated for participants who were in office and administrative support occupations (relative risk, 1.24); sales and related occupations (1.28); building and grounds cleaning and maintenance (1.37); transportation and material moving (1.38); food preparation and serving (1.41); production (1.47); protective services (1.51); construction and extraction (1.51); health care support (1.54); installation, maintenance, and repair (1.54); and military-specific occupations (2.04).

These findings come from adjusted analyses of data from the U.S. National Health Interview Survey for the years 2005 through 2009 that used participants in computer and mathematical occupations as the reference group. Overall, 19.5% of the sample reported having physician-diagnosed OA.

"Doctors should know that people working in these occupations have a risk factor that plays an important role in developing osteoarthritis," Dr. Wang said in an interview. "I don’t think they need to change occupations. But doctors may want to tell patients to use some preventive measures when they work in these occupations other than to just prescribe medications" for musculoskeletal symptoms, she said.

"We need more-detailed studies to determine what kinds of factors in these occupations play a role in the development of this disease," such as various biomechanical factors, added Dr. Wang, a statistician at Nassau University Medical Center in East Meadow, N.Y. Additionally, the role of duration of exposure requires further investigation.

Such research could eventually help inform the redesign of workplaces and work practices to minimize risk, she said. For example, "occupational therapists and physical medicine and rehabilitation specialists could develop facilities to help protect workers in these occupations further," Dr. Wang suggested.

Dr. Wang said that she and her coauthors had no relevant financial disclosures.

NEW YORK – In a chart review of 264 patients who underwent bariatric surgery, near-complete resolution of osteoarthritis knee pain was reported by many patients.

Specifically, 71% of those who underwent roux-en-Y gastric bypass (RYGB) reported resolution of knee pain associated with osteoarthritis (OA), as did 63% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 51% of those who underwent laparoscopic adjustable gastric banding (LAGB), according to coauthor Dr. Steven B. Abramson, who reported the findings at a rheumatology meeting sponsored by New York University.

"I predict bariatric surgery will become increasingly used as a treatment for osteoarthritis," said Dr. Abramson, professor of medicine and pathology and senior vice president and vice dean for education, faculty, and academic affairs and director of the division of rheumatology at NYU Langone Medical Center.

The study was originally presented by James X. Lui, a medical student at New York University, at the 2011 World Congress of the Osteoarthritis Research Society International (OARSI) (Abst. 17).

Patients underwent bariatric surgery at Bellevue Hospital Center between January 2008 and March 2010. The average age was 42.5 years, 92% were female, and the average presurgical body mass index was 44.2 kg/m². Of the 264 patients, LAGB was performed in 192, RYGB in 53, and LSG in 19. OA was present in 88% of the patients, making it the most common obesity-related comorbidity.

At a mean 17.2 months’ follow-up, patients lost 28.4% of excess weight. Significant differences in weight loss was seen among the three types of surgeries (P less than .001), with those undergoing RYGB losing 43.6% of excess weight, compared with 37.4% in those undergoing LSG and 23.3% in those who underwent LAGB.

The investigators used the Assessment of Obesity-Related Comorbidities (AORC) to rate 10 comorbid conditions. For OA, the severity was rated as ranging from 0 (pain not present) to 5 (awaiting or has undergone joint replacement). There was no difference in preoperative AORC mean scores between surgical groups.

The three bariatric surgeries produced statistically significant resolution of all obesity-related comorbidities (P less than .001). Scores on the AORC decreased the most overall in patients who underwent RYGB (66%) versus 60% for LSG and 44% for LAGB, respectively.

Comparing postoperative to preoperative scores, OA improved following all three types of surgeries. The greatest change was seen in those who underwent RYGB (2 points), compared with those who underwent LSG (1.6 point change) or LAGB (1.2 point change).

"I predict bariatric surgery will become increasingly used as a treatment for osteoarthritis."

The highest proportion of patients who had marked improvement of OA symptoms (postsurgical score of 0 on the AORC) was found in the RYGB group (71%), although good outcomes were also seen for 63% of the LSG and 51% of the LAGB groups.

Bariatric surgery lessened other comorbidities as well. For instance, resolution of hypertension was seen in 57% of the RYGB group, 29% of the LSG group, and 23% of the LAGB group. The effects on diabetes were less pronounced, with between 29% and 43% of patients reaching resolution, depending on the type of surgery.

Dr. Abramson suggests that the threshold for BMI as an indication for bariatric surgery could drop from BMI greater than 35 to BMI greater than 30 if there are comorbid conditions. "This includes a substantial percentage of U.S. patients with symptomatic knee OA who could become potential candidates for LAGB surgery if our preliminary studies were validated by prospective clinical trials," said Dr. Abramson.

Dr. Abramson also discussed the results of a study by Dr. Pascal Richette of the University of Paris who studied 140 obese patients with painful knee OA undergoing bariatric surgery (Ann. Rheum. Dis. 2011;70:139-44). As expected, a significant decrease in BMI resulted from surgery, as did a decrease in knee pain on the Western Ontario and McMaster Universities Osteoarthritis Index. Changes in levels of joint biomarkers, such as a significant increase of the N-terminal propeptide of type IIA collagen levels (a biomarker of cartilage synthesis) and a significant decrease in cartilage oligomeric protein (COMP) (a biomarker of cartilage degradation) suggests that structural effects on cartilage result from weight loss.

Dr. Abramson reported no relevant financial relationships.

NEW YORK – In a chart review of 264 patients who underwent bariatric surgery, near-complete resolution of osteoarthritis knee pain was reported by many patients.

Specifically, 71% of those who underwent roux-en-Y gastric bypass (RYGB) reported resolution of knee pain associated with osteoarthritis (OA), as did 63% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 51% of those who underwent laparoscopic adjustable gastric banding (LAGB), according to coauthor Dr. Steven B. Abramson, who reported the findings at a rheumatology meeting sponsored by New York University.

"I predict bariatric surgery will become increasingly used as a treatment for osteoarthritis," said Dr. Abramson, professor of medicine and pathology and senior vice president and vice dean for education, faculty, and academic affairs and director of the division of rheumatology at NYU Langone Medical Center.

The study was originally presented by James X. Lui, a medical student at New York University, at the 2011 World Congress of the Osteoarthritis Research Society International (OARSI) (Abst. 17).

Patients underwent bariatric surgery at Bellevue Hospital Center between January 2008 and March 2010. The average age was 42.5 years, 92% were female, and the average presurgical body mass index was 44.2 kg/m². Of the 264 patients, LAGB was performed in 192, RYGB in 53, and LSG in 19. OA was present in 88% of the patients, making it the most common obesity-related comorbidity.

At a mean 17.2 months’ follow-up, patients lost 28.4% of excess weight. Significant differences in weight loss was seen among the three types of surgeries (P less than .001), with those undergoing RYGB losing 43.6% of excess weight, compared with 37.4% in those undergoing LSG and 23.3% in those who underwent LAGB.

The investigators used the Assessment of Obesity-Related Comorbidities (AORC) to rate 10 comorbid conditions. For OA, the severity was rated as ranging from 0 (pain not present) to 5 (awaiting or has undergone joint replacement). There was no difference in preoperative AORC mean scores between surgical groups.

The three bariatric surgeries produced statistically significant resolution of all obesity-related comorbidities (P less than .001). Scores on the AORC decreased the most overall in patients who underwent RYGB (66%) versus 60% for LSG and 44% for LAGB, respectively.

Comparing postoperative to preoperative scores, OA improved following all three types of surgeries. The greatest change was seen in those who underwent RYGB (2 points), compared with those who underwent LSG (1.6 point change) or LAGB (1.2 point change).

"I predict bariatric surgery will become increasingly used as a treatment for osteoarthritis."

The highest proportion of patients who had marked improvement of OA symptoms (postsurgical score of 0 on the AORC) was found in the RYGB group (71%), although good outcomes were also seen for 63% of the LSG and 51% of the LAGB groups.

Bariatric surgery lessened other comorbidities as well. For instance, resolution of hypertension was seen in 57% of the RYGB group, 29% of the LSG group, and 23% of the LAGB group. The effects on diabetes were less pronounced, with between 29% and 43% of patients reaching resolution, depending on the type of surgery.

Dr. Abramson suggests that the threshold for BMI as an indication for bariatric surgery could drop from BMI greater than 35 to BMI greater than 30 if there are comorbid conditions. "This includes a substantial percentage of U.S. patients with symptomatic knee OA who could become potential candidates for LAGB surgery if our preliminary studies were validated by prospective clinical trials," said Dr. Abramson.

Dr. Abramson also discussed the results of a study by Dr. Pascal Richette of the University of Paris who studied 140 obese patients with painful knee OA undergoing bariatric surgery (Ann. Rheum. Dis. 2011;70:139-44). As expected, a significant decrease in BMI resulted from surgery, as did a decrease in knee pain on the Western Ontario and McMaster Universities Osteoarthritis Index. Changes in levels of joint biomarkers, such as a significant increase of the N-terminal propeptide of type IIA collagen levels (a biomarker of cartilage synthesis) and a significant decrease in cartilage oligomeric protein (COMP) (a biomarker of cartilage degradation) suggests that structural effects on cartilage result from weight loss.

Dr. Abramson reported no relevant financial relationships.

NEW YORK – In a chart review of 264 patients who underwent bariatric surgery, near-complete resolution of osteoarthritis knee pain was reported by many patients.

Specifically, 71% of those who underwent roux-en-Y gastric bypass (RYGB) reported resolution of knee pain associated with osteoarthritis (OA), as did 63% of those who underwent laparoscopic sleeve gastrectomy (LSG) and 51% of those who underwent laparoscopic adjustable gastric banding (LAGB), according to coauthor Dr. Steven B. Abramson, who reported the findings at a rheumatology meeting sponsored by New York University.

"I predict bariatric surgery will become increasingly used as a treatment for osteoarthritis," said Dr. Abramson, professor of medicine and pathology and senior vice president and vice dean for education, faculty, and academic affairs and director of the division of rheumatology at NYU Langone Medical Center.

The study was originally presented by James X. Lui, a medical student at New York University, at the 2011 World Congress of the Osteoarthritis Research Society International (OARSI) (Abst. 17).

Patients underwent bariatric surgery at Bellevue Hospital Center between January 2008 and March 2010. The average age was 42.5 years, 92% were female, and the average presurgical body mass index was 44.2 kg/m². Of the 264 patients, LAGB was performed in 192, RYGB in 53, and LSG in 19. OA was present in 88% of the patients, making it the most common obesity-related comorbidity.

At a mean 17.2 months’ follow-up, patients lost 28.4% of excess weight. Significant differences in weight loss was seen among the three types of surgeries (P less than .001), with those undergoing RYGB losing 43.6% of excess weight, compared with 37.4% in those undergoing LSG and 23.3% in those who underwent LAGB.

The investigators used the Assessment of Obesity-Related Comorbidities (AORC) to rate 10 comorbid conditions. For OA, the severity was rated as ranging from 0 (pain not present) to 5 (awaiting or has undergone joint replacement). There was no difference in preoperative AORC mean scores between surgical groups.

The three bariatric surgeries produced statistically significant resolution of all obesity-related comorbidities (P less than .001). Scores on the AORC decreased the most overall in patients who underwent RYGB (66%) versus 60% for LSG and 44% for LAGB, respectively.

Comparing postoperative to preoperative scores, OA improved following all three types of surgeries. The greatest change was seen in those who underwent RYGB (2 points), compared with those who underwent LSG (1.6 point change) or LAGB (1.2 point change).

"I predict bariatric surgery will become increasingly used as a treatment for osteoarthritis."

The highest proportion of patients who had marked improvement of OA symptoms (postsurgical score of 0 on the AORC) was found in the RYGB group (71%), although good outcomes were also seen for 63% of the LSG and 51% of the LAGB groups.

Bariatric surgery lessened other comorbidities as well. For instance, resolution of hypertension was seen in 57% of the RYGB group, 29% of the LSG group, and 23% of the LAGB group. The effects on diabetes were less pronounced, with between 29% and 43% of patients reaching resolution, depending on the type of surgery.

Dr. Abramson suggests that the threshold for BMI as an indication for bariatric surgery could drop from BMI greater than 35 to BMI greater than 30 if there are comorbid conditions. "This includes a substantial percentage of U.S. patients with symptomatic knee OA who could become potential candidates for LAGB surgery if our preliminary studies were validated by prospective clinical trials," said Dr. Abramson.

Dr. Abramson also discussed the results of a study by Dr. Pascal Richette of the University of Paris who studied 140 obese patients with painful knee OA undergoing bariatric surgery (Ann. Rheum. Dis. 2011;70:139-44). As expected, a significant decrease in BMI resulted from surgery, as did a decrease in knee pain on the Western Ontario and McMaster Universities Osteoarthritis Index. Changes in levels of joint biomarkers, such as a significant increase of the N-terminal propeptide of type IIA collagen levels (a biomarker of cartilage synthesis) and a significant decrease in cartilage oligomeric protein (COMP) (a biomarker of cartilage degradation) suggests that structural effects on cartilage result from weight loss.

Dr. Abramson reported no relevant financial relationships.

VICTORIA, B.C. – The risk for cardiovascular disease is greater in people with osteoarthritis, but the reason why remains unclear, researchers reported at the annual meeting of the Canadian Rheumatology Association.

Using diagnosis codes, a team led by M. Mushfiqur Rahman, a biostatistician at the Arthritis Research Center of the University of British Columbia, Vancouver and a doctoral student with the School of Population and Public Health there, compared risk by osteoarthritis (OA) in a random sample of adults from the province’s general population who were free of cardiovascular disease (CVD) at baseline.

In all, 12,624 people with prevalent or incident OA were matched with 61,131 unaffected people. With a mean follow-up of 13 years, there were 1.3 new cases of CVD per 100 person-years in the study sample, according to results reported in a poster session.

Analyses showed a statistically significant 19% increase in the risk of CVD in people who had OA vs. those without, after multivariate adjustment for a variety of potential confounders, such as hypertension, diabetes, and comorbidity burden.

In sex-stratified analyses, the elevation of risk was below average for men, whether they were younger than 65 years of age (12% increase in risk) or older than this age (13%). But it was notably above average for both women younger than age 65 years (41%) and women over this age (27%).

The mechanisms underlying the observed association are unknown, according to Mr. Rahman. Inflammation is one possibility, although there is no evidence to support this relationship at present.

"We cannot explain this relationship biologically," he commented in an interview. "Maybe reduced physical activity is a major factor here: After a diagnosis of OA, people are not as physically active as they were before."

"Prescription medication could also be a big factor," Mr. Rahman continued. "We didn’t adjust for any prescription drugs here," although patients with [OA] are more likely to be using acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids. "Those medications may have an effect [in elevating CVD risk]. We will see in the future."

The investigators are obtaining linked self-reported data that may shed further light on mechanisms. They will also be cross-checking the findings by assessing CVD mortality in patients with OA. If patients with OA prove to have higher CVD mortality, "that will be a good validation study."

In the meantime, physicians who see patients with OA may want to counsel them, "do more physical activity and take care of your heart," said Mr. Rahman.

Study participants were a random sample of individuals drawn from Population Data British Columbia for the years 1991 to 2009.

They were defined as having OA if the OA diagnostic code was used on either two or more visits to a health professional in 2 years or at least one discharge from the hospital. Similarly, they were defined as having CVD if they had a hospital record having a diagnosis code for ischemic heart disease, congestive heart failure, or stroke.

The mean age was about 58 years, and 59% of participants were women. About 16% had hypertension, 5% had hyperlipidemia, and 2% were obese. The mean Charlson comorbidity index was 0.41 in the OA group and 0.32 in the control group.

In addition to the elevated risk of CVD associated with OA (relative risk, 1.19), study results showed that participants were more likely to receive a CVD diagnosis if they had chronic obstructive pulmonary disease (1.18), had hypertension (1.38), were obese (1.21), or were in the lowest quintile of socioeconomic status (1.05). Also, risk increased with Charlson comorbidity index (1.11).

"There are some unmeasured confounders, for sure," Mr. Rahman acknowledged, noting that some variables, prescription drug use among them, were not available in the database used. Obesity was assessed from physician diagnoses instead of from body mass index; thus, the prevalence may have been underestimated. Also, "although we adjusted for [chronic obstructive pulmonary disease], smoking is an unmeasured confounder. And the physical activity level of the patients could be an unmeasured confounder, too."

Mr. Rahman disclosed that he had no relevant conflicts of interest.

VICTORIA, B.C. – The risk for cardiovascular disease is greater in people with osteoarthritis, but the reason why remains unclear, researchers reported at the annual meeting of the Canadian Rheumatology Association.

Using diagnosis codes, a team led by M. Mushfiqur Rahman, a biostatistician at the Arthritis Research Center of the University of British Columbia, Vancouver and a doctoral student with the School of Population and Public Health there, compared risk by osteoarthritis (OA) in a random sample of adults from the province’s general population who were free of cardiovascular disease (CVD) at baseline.

In all, 12,624 people with prevalent or incident OA were matched with 61,131 unaffected people. With a mean follow-up of 13 years, there were 1.3 new cases of CVD per 100 person-years in the study sample, according to results reported in a poster session.

Analyses showed a statistically significant 19% increase in the risk of CVD in people who had OA vs. those without, after multivariate adjustment for a variety of potential confounders, such as hypertension, diabetes, and comorbidity burden.

In sex-stratified analyses, the elevation of risk was below average for men, whether they were younger than 65 years of age (12% increase in risk) or older than this age (13%). But it was notably above average for both women younger than age 65 years (41%) and women over this age (27%).

The mechanisms underlying the observed association are unknown, according to Mr. Rahman. Inflammation is one possibility, although there is no evidence to support this relationship at present.

"We cannot explain this relationship biologically," he commented in an interview. "Maybe reduced physical activity is a major factor here: After a diagnosis of OA, people are not as physically active as they were before."

"Prescription medication could also be a big factor," Mr. Rahman continued. "We didn’t adjust for any prescription drugs here," although patients with [OA] are more likely to be using acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids. "Those medications may have an effect [in elevating CVD risk]. We will see in the future."

The investigators are obtaining linked self-reported data that may shed further light on mechanisms. They will also be cross-checking the findings by assessing CVD mortality in patients with OA. If patients with OA prove to have higher CVD mortality, "that will be a good validation study."

In the meantime, physicians who see patients with OA may want to counsel them, "do more physical activity and take care of your heart," said Mr. Rahman.

Study participants were a random sample of individuals drawn from Population Data British Columbia for the years 1991 to 2009.

They were defined as having OA if the OA diagnostic code was used on either two or more visits to a health professional in 2 years or at least one discharge from the hospital. Similarly, they were defined as having CVD if they had a hospital record having a diagnosis code for ischemic heart disease, congestive heart failure, or stroke.

The mean age was about 58 years, and 59% of participants were women. About 16% had hypertension, 5% had hyperlipidemia, and 2% were obese. The mean Charlson comorbidity index was 0.41 in the OA group and 0.32 in the control group.

In addition to the elevated risk of CVD associated with OA (relative risk, 1.19), study results showed that participants were more likely to receive a CVD diagnosis if they had chronic obstructive pulmonary disease (1.18), had hypertension (1.38), were obese (1.21), or were in the lowest quintile of socioeconomic status (1.05). Also, risk increased with Charlson comorbidity index (1.11).

"There are some unmeasured confounders, for sure," Mr. Rahman acknowledged, noting that some variables, prescription drug use among them, were not available in the database used. Obesity was assessed from physician diagnoses instead of from body mass index; thus, the prevalence may have been underestimated. Also, "although we adjusted for [chronic obstructive pulmonary disease], smoking is an unmeasured confounder. And the physical activity level of the patients could be an unmeasured confounder, too."

Mr. Rahman disclosed that he had no relevant conflicts of interest.

VICTORIA, B.C. – The risk for cardiovascular disease is greater in people with osteoarthritis, but the reason why remains unclear, researchers reported at the annual meeting of the Canadian Rheumatology Association.

Using diagnosis codes, a team led by M. Mushfiqur Rahman, a biostatistician at the Arthritis Research Center of the University of British Columbia, Vancouver and a doctoral student with the School of Population and Public Health there, compared risk by osteoarthritis (OA) in a random sample of adults from the province’s general population who were free of cardiovascular disease (CVD) at baseline.

In all, 12,624 people with prevalent or incident OA were matched with 61,131 unaffected people. With a mean follow-up of 13 years, there were 1.3 new cases of CVD per 100 person-years in the study sample, according to results reported in a poster session.

Analyses showed a statistically significant 19% increase in the risk of CVD in people who had OA vs. those without, after multivariate adjustment for a variety of potential confounders, such as hypertension, diabetes, and comorbidity burden.

In sex-stratified analyses, the elevation of risk was below average for men, whether they were younger than 65 years of age (12% increase in risk) or older than this age (13%). But it was notably above average for both women younger than age 65 years (41%) and women over this age (27%).

The mechanisms underlying the observed association are unknown, according to Mr. Rahman. Inflammation is one possibility, although there is no evidence to support this relationship at present.

"We cannot explain this relationship biologically," he commented in an interview. "Maybe reduced physical activity is a major factor here: After a diagnosis of OA, people are not as physically active as they were before."

"Prescription medication could also be a big factor," Mr. Rahman continued. "We didn’t adjust for any prescription drugs here," although patients with [OA] are more likely to be using acetaminophen, nonsteroidal anti-inflammatory drugs, and opioids. "Those medications may have an effect [in elevating CVD risk]. We will see in the future."

The investigators are obtaining linked self-reported data that may shed further light on mechanisms. They will also be cross-checking the findings by assessing CVD mortality in patients with OA. If patients with OA prove to have higher CVD mortality, "that will be a good validation study."

In the meantime, physicians who see patients with OA may want to counsel them, "do more physical activity and take care of your heart," said Mr. Rahman.

Study participants were a random sample of individuals drawn from Population Data British Columbia for the years 1991 to 2009.

They were defined as having OA if the OA diagnostic code was used on either two or more visits to a health professional in 2 years or at least one discharge from the hospital. Similarly, they were defined as having CVD if they had a hospital record having a diagnosis code for ischemic heart disease, congestive heart failure, or stroke.

The mean age was about 58 years, and 59% of participants were women. About 16% had hypertension, 5% had hyperlipidemia, and 2% were obese. The mean Charlson comorbidity index was 0.41 in the OA group and 0.32 in the control group.

In addition to the elevated risk of CVD associated with OA (relative risk, 1.19), study results showed that participants were more likely to receive a CVD diagnosis if they had chronic obstructive pulmonary disease (1.18), had hypertension (1.38), were obese (1.21), or were in the lowest quintile of socioeconomic status (1.05). Also, risk increased with Charlson comorbidity index (1.11).

"There are some unmeasured confounders, for sure," Mr. Rahman acknowledged, noting that some variables, prescription drug use among them, were not available in the database used. Obesity was assessed from physician diagnoses instead of from body mass index; thus, the prevalence may have been underestimated. Also, "although we adjusted for [chronic obstructive pulmonary disease], smoking is an unmeasured confounder. And the physical activity level of the patients could be an unmeasured confounder, too."

Mr. Rahman disclosed that he had no relevant conflicts of interest.

CHICAGO – Patients who received treatment with a nonsteroidal anti-inflammatory drug following a first-time myocardial infarction had a significantly increased rate of subsequent atrial fibrillation or stroke, based on data collected since 1997 from more than 88,000 Danish residents.

Compared with patients who did not receive an NSAID, those given at least one prescription of a NSAID following hospitalization for a first-time myocardial infarction (MI) had statistically significant increased rates of subsequent atrial fibrillation, 23%, and of a subsequent stroke, 25%, in an analysis that adjusted for possible confounders, Dr. Anne-Marie Schjerning Olsen and her associates reported in a poster at the meeting.

The findings add to existing evidence that NSAID treatment poses a cardiovascular risk to certain patients. Further, the results highlight the need to assess cardiovascular risk and balance that risk from NSAID treatment against its possible benefit before prescribing these drugs, they said.

Last year, Dr. Olsen and her associates reported results from another analysis using the same database showing that NSAID use by patients following a MI boosted their risk for death or a second MI.

The new study reviewed nationwide hospitalization and pharmacy records for 88,458 Danish residents who were at least 30 years old, were hospitalized for a first-time MI during 1997-2009 and had no history of prior atrial fibrillation. Their mean age was 68 years, and 64% were men. During follow-up, 46% of the patients filled at least one prescription for an NSAID. In addition, during the study period, 9,578 of the post-MI patients were hospitalized for atrial fibrillation, and 7,687 were hospitalized for a stroke.

Among the NSAID users, the incidence of atrial fibrillation in the post-MI patients was 26.9 cases/1,000 person-years, and the stroke incidence was 21.2 cases/1,000 person-years, reported Dr. Olsen, a cardiology researcher at Gentofte Hospital in Copenhagen, and her associates.

In an analysis that adjusted for age, gender, calendar year, concomitant drug use, and comorbidities, use of any type of NSAID boosted the atrial fibrillation risk by 23% and the stroke risk by 25%, compared with the risk in patients who did not take an NSAID.

The greatest adverse effect was linked with rofecoxib (Vioxx) treatment, which was associated with a 35% increased risk for atrial fibrillation and a 2.5-fold increased risk for stroke, both statistically significant differences, compared with non–NSAID users.

Other individual NSAIDs in the analysis included celecoxib (Celebrex), which was linked with a statistically significant, roughly 80% increased rate of stroke compared with non–NSAID users. Celecoxib did not have a significant impact on atrial fibrillation rate. Ibuprofen and diclofenac each boosted the rate of atrial fibrillation and of stroke by about the same amount as did all of the NSAIDs together. Naproxen did not have a statistically significant effect on either end point.

Dr. Olsen said that she had no disclosures.

CHICAGO – Patients who received treatment with a nonsteroidal anti-inflammatory drug following a first-time myocardial infarction had a significantly increased rate of subsequent atrial fibrillation or stroke, based on data collected since 1997 from more than 88,000 Danish residents.

Compared with patients who did not receive an NSAID, those given at least one prescription of a NSAID following hospitalization for a first-time myocardial infarction (MI) had statistically significant increased rates of subsequent atrial fibrillation, 23%, and of a subsequent stroke, 25%, in an analysis that adjusted for possible confounders, Dr. Anne-Marie Schjerning Olsen and her associates reported in a poster at the meeting.

The findings add to existing evidence that NSAID treatment poses a cardiovascular risk to certain patients. Further, the results highlight the need to assess cardiovascular risk and balance that risk from NSAID treatment against its possible benefit before prescribing these drugs, they said.

Last year, Dr. Olsen and her associates reported results from another analysis using the same database showing that NSAID use by patients following a MI boosted their risk for death or a second MI.

The new study reviewed nationwide hospitalization and pharmacy records for 88,458 Danish residents who were at least 30 years old, were hospitalized for a first-time MI during 1997-2009 and had no history of prior atrial fibrillation. Their mean age was 68 years, and 64% were men. During follow-up, 46% of the patients filled at least one prescription for an NSAID. In addition, during the study period, 9,578 of the post-MI patients were hospitalized for atrial fibrillation, and 7,687 were hospitalized for a stroke.

Among the NSAID users, the incidence of atrial fibrillation in the post-MI patients was 26.9 cases/1,000 person-years, and the stroke incidence was 21.2 cases/1,000 person-years, reported Dr. Olsen, a cardiology researcher at Gentofte Hospital in Copenhagen, and her associates.

In an analysis that adjusted for age, gender, calendar year, concomitant drug use, and comorbidities, use of any type of NSAID boosted the atrial fibrillation risk by 23% and the stroke risk by 25%, compared with the risk in patients who did not take an NSAID.

The greatest adverse effect was linked with rofecoxib (Vioxx) treatment, which was associated with a 35% increased risk for atrial fibrillation and a 2.5-fold increased risk for stroke, both statistically significant differences, compared with non–NSAID users.

Other individual NSAIDs in the analysis included celecoxib (Celebrex), which was linked with a statistically significant, roughly 80% increased rate of stroke compared with non–NSAID users. Celecoxib did not have a significant impact on atrial fibrillation rate. Ibuprofen and diclofenac each boosted the rate of atrial fibrillation and of stroke by about the same amount as did all of the NSAIDs together. Naproxen did not have a statistically significant effect on either end point.

Dr. Olsen said that she had no disclosures.

CHICAGO – Patients who received treatment with a nonsteroidal anti-inflammatory drug following a first-time myocardial infarction had a significantly increased rate of subsequent atrial fibrillation or stroke, based on data collected since 1997 from more than 88,000 Danish residents.

Compared with patients who did not receive an NSAID, those given at least one prescription of a NSAID following hospitalization for a first-time myocardial infarction (MI) had statistically significant increased rates of subsequent atrial fibrillation, 23%, and of a subsequent stroke, 25%, in an analysis that adjusted for possible confounders, Dr. Anne-Marie Schjerning Olsen and her associates reported in a poster at the meeting.

The findings add to existing evidence that NSAID treatment poses a cardiovascular risk to certain patients. Further, the results highlight the need to assess cardiovascular risk and balance that risk from NSAID treatment against its possible benefit before prescribing these drugs, they said.

Last year, Dr. Olsen and her associates reported results from another analysis using the same database showing that NSAID use by patients following a MI boosted their risk for death or a second MI.

The new study reviewed nationwide hospitalization and pharmacy records for 88,458 Danish residents who were at least 30 years old, were hospitalized for a first-time MI during 1997-2009 and had no history of prior atrial fibrillation. Their mean age was 68 years, and 64% were men. During follow-up, 46% of the patients filled at least one prescription for an NSAID. In addition, during the study period, 9,578 of the post-MI patients were hospitalized for atrial fibrillation, and 7,687 were hospitalized for a stroke.

Among the NSAID users, the incidence of atrial fibrillation in the post-MI patients was 26.9 cases/1,000 person-years, and the stroke incidence was 21.2 cases/1,000 person-years, reported Dr. Olsen, a cardiology researcher at Gentofte Hospital in Copenhagen, and her associates.

In an analysis that adjusted for age, gender, calendar year, concomitant drug use, and comorbidities, use of any type of NSAID boosted the atrial fibrillation risk by 23% and the stroke risk by 25%, compared with the risk in patients who did not take an NSAID.

The greatest adverse effect was linked with rofecoxib (Vioxx) treatment, which was associated with a 35% increased risk for atrial fibrillation and a 2.5-fold increased risk for stroke, both statistically significant differences, compared with non–NSAID users.

Other individual NSAIDs in the analysis included celecoxib (Celebrex), which was linked with a statistically significant, roughly 80% increased rate of stroke compared with non–NSAID users. Celecoxib did not have a significant impact on atrial fibrillation rate. Ibuprofen and diclofenac each boosted the rate of atrial fibrillation and of stroke by about the same amount as did all of the NSAIDs together. Naproxen did not have a statistically significant effect on either end point.

Dr. Olsen said that she had no disclosures.

The American College of Rheumatology’s latest recommendations on treatment of osteoarthritis place new emphasis on early use of nonpharmacologic therapies, such as tai chi and acupuncture and advise against use of glucosamine/chondroitin.

"We placed an emphasis on non-pharmacologic treatments. ... Reimbursement is one of the issues. We really wanted to put some gravitas on the evaluation of the non-pharmacologic modalities. ... We wanted providers to be aware of what’s available for patients, what’s beneficial for patients, and what the recommendations of a group of experts are on how they should use these for patients even before they consider pharmacologic agents."

The new recommendations, which are ACR’s first to address hand OA, are also the first to be developed using a formal process for evidence-based recommendations. They "were derived using a state-of-the-art approach utilizing evidence from the most recent and best methodological quality systematic review of the individual treatment modalities in patients with osteoarthritis of the hand, hip, or knee," lead author Dr. Marc C. Hochberg said in an interview.

The approach, called Grades of Recommendation Assessment, Development, and Evaluation (GRADE), has been adopted by the World Health Organization, the Cochrane Collaboration, and the Agency for Healthcare Research and Quality, along with numerous professional organizations. The American College of Rheumatology has now officially adopted GRADE for future recommendations, said Dr. Hochberg, professor of medicine and epidemiology and public health and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The new recommendations, which replace those issued in 2000, are also the first to be developed by a multidisciplinary panel that included primary care physicians, physiatrists, and geriatricians along with rheumatologists (both academic and private practice), an orthopedic surgeon, and both physical and occupational therapists. Based on the strength of the evidence and using real-life patient examples, the panelists ranked each recommendation as either strong in favor of use, weak (or conditional), no recommendation, weak or conditional recommendation not to use, and strong recommendation not to use (Arthritis Care Res. 2012;64:465-74).

"These are much more real-world recommendations based on patients who present for consultation and would be applicable for the provider in their office situation when they see a patient. ... They’re meant for primary care physicians as well as rheumatologists," Dr. Hochberg said.

In fact, the new emphasis on non-pharmacologic therapies is done for the benefit of primary care physicians. "In the short period of time that primary care providers have to spend with their patients, [non-pharmacologic therapies are] often overlooked," said Dr. Hochberg.

For hand OA, the panel conditionally recommended evaluation of the patient’s ability to perform activities of daily living, instruction in joint protection techniques, assistive devices as needed, instruction in the use of thermal modalities, and splints for patients with trapeziometacarpal joint OA. Conditional pharmacologic recommendations for hand OA include topical capsaicin, topical nonsteroidal anti-inflammatory drugs (NSAIDs), and oral NSAIDs. The panel also conditionally recommended against the use of intra-articular therapies and opioid analgesics.

No strong recommendations were made for hand OA. "We only provided conditional recommendations for hand OA, which points to the relative dearth of studies in this area and then lack of good quality evidence to support treatments for it. Hand OA is an area that is in need of well-designed, large placebo-controlled and active-comparator studies," Dr. Hochberg commented.

For initial management of knee OA, the panel strongly recommended the nonpharmacologic interventions of participation in cardiovascular (aerobic) and/or resistance land-based exercise, participation in aquatic exercise, and weight loss if indicated. They conditionally recommended a long list of nonpharmacologic interventions, including participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial intervention, use of medially directed patellar taping, wedged insoles, thermal agents, walking aids as needed, participation in tai chi programs, treatment with Chinese acupuncture, and transcutaneous electrical stimulation.

No strong pharmacologic recommendations were made for the initial treatment of knee OA. Conditional recommendations included one of the following: acetaminophen, oral NSAIDs, topical NSAIDs, tramadol, or intra-articular corticosteroid injections. Conditional recommendations were made to not use chondroitin sulfate, glucosamine, or topical capsaicin.

Strong nonpharmacologic recommendations for hip OA included participation in cardiovascular and/or resistance land-based exercise, participation in aquatic exercise, and weight loss, if indicated. Conditional nonpharmacologic recommendations included participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial interventions, instruction in the use of thermal agents, and walking aids as needed.

As with knee OA, conditional pharmacologic recommendations for hip OA include one of either acetaminophen, oral NSAIDs, tramadol or intra-articular corticosteroid injections. As well, chondroitin sulfate and glucosamine were conditionally recommended against.

Dr. Hochberg acknowledged that despite the panel’s use of the rigorous evidence-based approach, the conditional recommendations for use of tai chi and acupuncture might prove controversial, as might the conditional recommendations against the use of intra-articular therapies for hand OA and glucosamine/chondroitin. The non-recommendation for the latter nutraceuticals was based on negative studies conducted on the products that are sold over the counter in the United States and Canada, which are different from the pharmaceutically produced preparations tested and sold in Europe, Dr. Hochberg explained.

Of note, there are no strong recommendations for pharmaceutical treatment of any joint area.

Dr. Hochberg disclosed that he has financial relationships with Abbott, Amgen, AstraZeneca, Bayer Health Care, Bioiberica, Bristol-Myers Squibb, CombinatoRx, Covidien, Eli Lilly, Genentech, GlaxoSmithKline, Hoffman-La Roche, Merck, Merck Serono International, NicOx, Novartis, Pfizer, Pozen, Rand Corporation, Sanofi-Aventis, Smith & Nephew, Stryker Biotech, Theralogix, TransPharma Medical, and UCB. He receives research support from the NIH.

The American College of Rheumatology’s latest recommendations on treatment of osteoarthritis place new emphasis on early use of nonpharmacologic therapies, such as tai chi and acupuncture and advise against use of glucosamine/chondroitin.

"We placed an emphasis on non-pharmacologic treatments. ... Reimbursement is one of the issues. We really wanted to put some gravitas on the evaluation of the non-pharmacologic modalities. ... We wanted providers to be aware of what’s available for patients, what’s beneficial for patients, and what the recommendations of a group of experts are on how they should use these for patients even before they consider pharmacologic agents."

The new recommendations, which are ACR’s first to address hand OA, are also the first to be developed using a formal process for evidence-based recommendations. They "were derived using a state-of-the-art approach utilizing evidence from the most recent and best methodological quality systematic review of the individual treatment modalities in patients with osteoarthritis of the hand, hip, or knee," lead author Dr. Marc C. Hochberg said in an interview.

The approach, called Grades of Recommendation Assessment, Development, and Evaluation (GRADE), has been adopted by the World Health Organization, the Cochrane Collaboration, and the Agency for Healthcare Research and Quality, along with numerous professional organizations. The American College of Rheumatology has now officially adopted GRADE for future recommendations, said Dr. Hochberg, professor of medicine and epidemiology and public health and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The new recommendations, which replace those issued in 2000, are also the first to be developed by a multidisciplinary panel that included primary care physicians, physiatrists, and geriatricians along with rheumatologists (both academic and private practice), an orthopedic surgeon, and both physical and occupational therapists. Based on the strength of the evidence and using real-life patient examples, the panelists ranked each recommendation as either strong in favor of use, weak (or conditional), no recommendation, weak or conditional recommendation not to use, and strong recommendation not to use (Arthritis Care Res. 2012;64:465-74).

"These are much more real-world recommendations based on patients who present for consultation and would be applicable for the provider in their office situation when they see a patient. ... They’re meant for primary care physicians as well as rheumatologists," Dr. Hochberg said.

In fact, the new emphasis on non-pharmacologic therapies is done for the benefit of primary care physicians. "In the short period of time that primary care providers have to spend with their patients, [non-pharmacologic therapies are] often overlooked," said Dr. Hochberg.

For hand OA, the panel conditionally recommended evaluation of the patient’s ability to perform activities of daily living, instruction in joint protection techniques, assistive devices as needed, instruction in the use of thermal modalities, and splints for patients with trapeziometacarpal joint OA. Conditional pharmacologic recommendations for hand OA include topical capsaicin, topical nonsteroidal anti-inflammatory drugs (NSAIDs), and oral NSAIDs. The panel also conditionally recommended against the use of intra-articular therapies and opioid analgesics.

No strong recommendations were made for hand OA. "We only provided conditional recommendations for hand OA, which points to the relative dearth of studies in this area and then lack of good quality evidence to support treatments for it. Hand OA is an area that is in need of well-designed, large placebo-controlled and active-comparator studies," Dr. Hochberg commented.

For initial management of knee OA, the panel strongly recommended the nonpharmacologic interventions of participation in cardiovascular (aerobic) and/or resistance land-based exercise, participation in aquatic exercise, and weight loss if indicated. They conditionally recommended a long list of nonpharmacologic interventions, including participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial intervention, use of medially directed patellar taping, wedged insoles, thermal agents, walking aids as needed, participation in tai chi programs, treatment with Chinese acupuncture, and transcutaneous electrical stimulation.

No strong pharmacologic recommendations were made for the initial treatment of knee OA. Conditional recommendations included one of the following: acetaminophen, oral NSAIDs, topical NSAIDs, tramadol, or intra-articular corticosteroid injections. Conditional recommendations were made to not use chondroitin sulfate, glucosamine, or topical capsaicin.

Strong nonpharmacologic recommendations for hip OA included participation in cardiovascular and/or resistance land-based exercise, participation in aquatic exercise, and weight loss, if indicated. Conditional nonpharmacologic recommendations included participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial interventions, instruction in the use of thermal agents, and walking aids as needed.

As with knee OA, conditional pharmacologic recommendations for hip OA include one of either acetaminophen, oral NSAIDs, tramadol or intra-articular corticosteroid injections. As well, chondroitin sulfate and glucosamine were conditionally recommended against.

Dr. Hochberg acknowledged that despite the panel’s use of the rigorous evidence-based approach, the conditional recommendations for use of tai chi and acupuncture might prove controversial, as might the conditional recommendations against the use of intra-articular therapies for hand OA and glucosamine/chondroitin. The non-recommendation for the latter nutraceuticals was based on negative studies conducted on the products that are sold over the counter in the United States and Canada, which are different from the pharmaceutically produced preparations tested and sold in Europe, Dr. Hochberg explained.

Of note, there are no strong recommendations for pharmaceutical treatment of any joint area.

Dr. Hochberg disclosed that he has financial relationships with Abbott, Amgen, AstraZeneca, Bayer Health Care, Bioiberica, Bristol-Myers Squibb, CombinatoRx, Covidien, Eli Lilly, Genentech, GlaxoSmithKline, Hoffman-La Roche, Merck, Merck Serono International, NicOx, Novartis, Pfizer, Pozen, Rand Corporation, Sanofi-Aventis, Smith & Nephew, Stryker Biotech, Theralogix, TransPharma Medical, and UCB. He receives research support from the NIH.

The American College of Rheumatology’s latest recommendations on treatment of osteoarthritis place new emphasis on early use of nonpharmacologic therapies, such as tai chi and acupuncture and advise against use of glucosamine/chondroitin.

"We placed an emphasis on non-pharmacologic treatments. ... Reimbursement is one of the issues. We really wanted to put some gravitas on the evaluation of the non-pharmacologic modalities. ... We wanted providers to be aware of what’s available for patients, what’s beneficial for patients, and what the recommendations of a group of experts are on how they should use these for patients even before they consider pharmacologic agents."

The new recommendations, which are ACR’s first to address hand OA, are also the first to be developed using a formal process for evidence-based recommendations. They "were derived using a state-of-the-art approach utilizing evidence from the most recent and best methodological quality systematic review of the individual treatment modalities in patients with osteoarthritis of the hand, hip, or knee," lead author Dr. Marc C. Hochberg said in an interview.

The approach, called Grades of Recommendation Assessment, Development, and Evaluation (GRADE), has been adopted by the World Health Organization, the Cochrane Collaboration, and the Agency for Healthcare Research and Quality, along with numerous professional organizations. The American College of Rheumatology has now officially adopted GRADE for future recommendations, said Dr. Hochberg, professor of medicine and epidemiology and public health and head of the division of rheumatology and clinical immunology at the University of Maryland, Baltimore.

The new recommendations, which replace those issued in 2000, are also the first to be developed by a multidisciplinary panel that included primary care physicians, physiatrists, and geriatricians along with rheumatologists (both academic and private practice), an orthopedic surgeon, and both physical and occupational therapists. Based on the strength of the evidence and using real-life patient examples, the panelists ranked each recommendation as either strong in favor of use, weak (or conditional), no recommendation, weak or conditional recommendation not to use, and strong recommendation not to use (Arthritis Care Res. 2012;64:465-74).

"These are much more real-world recommendations based on patients who present for consultation and would be applicable for the provider in their office situation when they see a patient. ... They’re meant for primary care physicians as well as rheumatologists," Dr. Hochberg said.

In fact, the new emphasis on non-pharmacologic therapies is done for the benefit of primary care physicians. "In the short period of time that primary care providers have to spend with their patients, [non-pharmacologic therapies are] often overlooked," said Dr. Hochberg.

For hand OA, the panel conditionally recommended evaluation of the patient’s ability to perform activities of daily living, instruction in joint protection techniques, assistive devices as needed, instruction in the use of thermal modalities, and splints for patients with trapeziometacarpal joint OA. Conditional pharmacologic recommendations for hand OA include topical capsaicin, topical nonsteroidal anti-inflammatory drugs (NSAIDs), and oral NSAIDs. The panel also conditionally recommended against the use of intra-articular therapies and opioid analgesics.

No strong recommendations were made for hand OA. "We only provided conditional recommendations for hand OA, which points to the relative dearth of studies in this area and then lack of good quality evidence to support treatments for it. Hand OA is an area that is in need of well-designed, large placebo-controlled and active-comparator studies," Dr. Hochberg commented.

For initial management of knee OA, the panel strongly recommended the nonpharmacologic interventions of participation in cardiovascular (aerobic) and/or resistance land-based exercise, participation in aquatic exercise, and weight loss if indicated. They conditionally recommended a long list of nonpharmacologic interventions, including participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial intervention, use of medially directed patellar taping, wedged insoles, thermal agents, walking aids as needed, participation in tai chi programs, treatment with Chinese acupuncture, and transcutaneous electrical stimulation.

No strong pharmacologic recommendations were made for the initial treatment of knee OA. Conditional recommendations included one of the following: acetaminophen, oral NSAIDs, topical NSAIDs, tramadol, or intra-articular corticosteroid injections. Conditional recommendations were made to not use chondroitin sulfate, glucosamine, or topical capsaicin.

Strong nonpharmacologic recommendations for hip OA included participation in cardiovascular and/or resistance land-based exercise, participation in aquatic exercise, and weight loss, if indicated. Conditional nonpharmacologic recommendations included participation in self-management programs, manual therapy in combination with supervised exercise, psychosocial interventions, instruction in the use of thermal agents, and walking aids as needed.

As with knee OA, conditional pharmacologic recommendations for hip OA include one of either acetaminophen, oral NSAIDs, tramadol or intra-articular corticosteroid injections. As well, chondroitin sulfate and glucosamine were conditionally recommended against.

Dr. Hochberg acknowledged that despite the panel’s use of the rigorous evidence-based approach, the conditional recommendations for use of tai chi and acupuncture might prove controversial, as might the conditional recommendations against the use of intra-articular therapies for hand OA and glucosamine/chondroitin. The non-recommendation for the latter nutraceuticals was based on negative studies conducted on the products that are sold over the counter in the United States and Canada, which are different from the pharmaceutically produced preparations tested and sold in Europe, Dr. Hochberg explained.

Of note, there are no strong recommendations for pharmaceutical treatment of any joint area.

Dr. Hochberg disclosed that he has financial relationships with Abbott, Amgen, AstraZeneca, Bayer Health Care, Bioiberica, Bristol-Myers Squibb, CombinatoRx, Covidien, Eli Lilly, Genentech, GlaxoSmithKline, Hoffman-La Roche, Merck, Merck Serono International, NicOx, Novartis, Pfizer, Pozen, Rand Corporation, Sanofi-Aventis, Smith & Nephew, Stryker Biotech, Theralogix, TransPharma Medical, and UCB. He receives research support from the NIH.

LAS VEGAS – Even the most careful clinical pain management cannot eliminate the risk of opioid misuse in patients with a history of addiction, but good communication can help reduce the risk significantly, Dr. Sean Mackey said during a psychopharmacology conference sponsored by the Nevada Psychiatric Association.

"Some of the basic tenets of managing patients with chronic opioids are education, education, and education," said Dr. Mackey, chief of the pain management division at Stanford (Calif.) University. "It’s important to set expectations for people with chronic pain. The cure is not the goal; we’re there to help improve quality of life and get people back in control of their lives, better manage pain, and improve physical functioning."

According to best estimates from existing medical literature, the prevalence of comorbid chronic pain and opioid addiction in the United States ranges between 0.6-1.2 million people, mainly affecting young adults and the elderly. But that estimate might be conservative. A June 2011 report from the Institute of Medicine noted that chronic pain affects 116 million Americans – more than the total affected by heart disease, cancer and diabetes combined – at a cost of $560-$630 billion per year. Chronic pain "is the No. 1 reason people are out of work, hitting people often at their most productive ages, and also hitting people more and more as we advance in years," Dr. Mackey said.

In his opinion, optimal management of patients with chronic pain consists of a multidisciplinary approach "in which we bring together specialists who take care of pharmacologic aspects to pain management, physical and occupational therapy approaches, psychological/behavioral approaches, and complementary and alternative medicine approaches. It’s a team-based approach. A lot of this is dealing with body education: helping people understand what is safe for them to do and what is not safe for them to do, alleviating their fears about their body.

"We do procedural approaches as well, everything from simple trigger-point injections to spinal cord stimulation – all in the context of a functional rehabilitation approach."

Psychological approaches include giving patients time-contingent dosing of medications, "on-the-clock rather than when they are experiencing pain," said Dr. Mackey, who also directs the Stanford Systems Neuroscience and Pain Lab. "We also give positive reinforcement for healthy behaviors, negative reinforcement for unhealthy behaviors, and we get their spouse involved, because their involvement is crucial to success."

To responsibly prescribe opioids, Dr. Mackey recommends that physicians become familiar with the Federation of State Medical Boards’ Model Policy for the Treatment of Pain. He also recommends the book "Responsible Opioid Prescribing: A Physician’s Guide," by pain expert Dr. Scott M. Fishman (Waterford, Mich.: Waterford Life Sciences, 2007). This book incorporates the tenets set out in the FSMB’s model policy. "The basic tenet of this model is that pain management is a moral imperative; we should all be aware of the problems of pain management and the use of opioids may be necessary for our patients in pain," Dr. Mackey said.

The model also emphasizes that the use of opioids other than for a legitimate medical purpose "does pose a problem, that we have a responsibility to minimize the abuse and diversion with risk mitigation, [and] that physicians may deviate from recommended treatment when they have good cause. That means we’re not trying to box people in to rigid policies."

His recommended strategy for prescribing opioids in patients with a history of substance abuse starts with a careful assessment and formation of an appropriate differential diagnosis and a psychological assessment, including risk of addictive disorders. Next, have patients sign an informed consent for opioid treatment. "Our consent form has changed somewhat," Dr. Mackey said. "I’m giving patients more information about the potential for organ toxicity and the endocrine abnormalities that can occur as a consequence of opioid use, such as depression of sex hormones."

This is followed by asking patients to sign an opioid treatment agreement that informs them about your standard opioid prescribing policy, such as stating that medication will be refilled during regular office hours, Mondays through Fridays, that lost narcotic medication cannot be replaced, and that stolen narcotic medication may be replaced provided they obtain a police report and are seen in the office.

Dr. Mackey then begins patients on an appropriate trial of opioid therapy with or without adjunctive medications.

"I use the word ‘trial’ because people often think this is meant to be a long-term use of these medications when we try to make it clear right up front that use is for the short term," he explained. "I then assess and reassess their level of pain and function."

He also recommends that clinicians follow the "four As" for ongoing monitoring of pain treatment outcomes, a system developed by Steven D. Passik, Ph.D. These are analgesia (pain relief), activities of daily living (psychosocial functioning), adverse events (side effects), and aberrant drug taking (addiction-related outcomes).

"If you focus on those four As and document them, you can usually stay out of trouble when prescribing these medications," Dr. Mackey said. "Document everything in the medical record, because 95% of the problems that doctors run into with their state medical board have to do with failure to appropriately document."

Other efforts to mitigate risk include using predictive tools, urine drug testing when appropriate, and using your state’s prescription monitoring program. "Use family and friends and others to gather information to make sure that the patient is using the medication appropriately," he advised.

Potential signs of abuse and diversion include patients "who show up at the end of office hours and arrive without an appointment, or who often arrive right when your staff is trying to leave for the day," Dr. Mackey said. "They’re typically reluctant to have a thorough physical exam and don’t give you past medical records, they don’t follow up with appointments, and they have very unusual stories."

Dr. Mackey disclosed that he has received research funding from the National Institutes of Health, the Dodie and John Rosekrans Pain Research Endowment, and the Redlich Pain Research Endowment.

LAS VEGAS – Even the most careful clinical pain management cannot eliminate the risk of opioid misuse in patients with a history of addiction, but good communication can help reduce the risk significantly, Dr. Sean Mackey said during a psychopharmacology conference sponsored by the Nevada Psychiatric Association.

"Some of the basic tenets of managing patients with chronic opioids are education, education, and education," said Dr. Mackey, chief of the pain management division at Stanford (Calif.) University. "It’s important to set expectations for people with chronic pain. The cure is not the goal; we’re there to help improve quality of life and get people back in control of their lives, better manage pain, and improve physical functioning."

According to best estimates from existing medical literature, the prevalence of comorbid chronic pain and opioid addiction in the United States ranges between 0.6-1.2 million people, mainly affecting young adults and the elderly. But that estimate might be conservative. A June 2011 report from the Institute of Medicine noted that chronic pain affects 116 million Americans – more than the total affected by heart disease, cancer and diabetes combined – at a cost of $560-$630 billion per year. Chronic pain "is the No. 1 reason people are out of work, hitting people often at their most productive ages, and also hitting people more and more as we advance in years," Dr. Mackey said.

In his opinion, optimal management of patients with chronic pain consists of a multidisciplinary approach "in which we bring together specialists who take care of pharmacologic aspects to pain management, physical and occupational therapy approaches, psychological/behavioral approaches, and complementary and alternative medicine approaches. It’s a team-based approach. A lot of this is dealing with body education: helping people understand what is safe for them to do and what is not safe for them to do, alleviating their fears about their body.

"We do procedural approaches as well, everything from simple trigger-point injections to spinal cord stimulation – all in the context of a functional rehabilitation approach."

Psychological approaches include giving patients time-contingent dosing of medications, "on-the-clock rather than when they are experiencing pain," said Dr. Mackey, who also directs the Stanford Systems Neuroscience and Pain Lab. "We also give positive reinforcement for healthy behaviors, negative reinforcement for unhealthy behaviors, and we get their spouse involved, because their involvement is crucial to success."

To responsibly prescribe opioids, Dr. Mackey recommends that physicians become familiar with the Federation of State Medical Boards’ Model Policy for the Treatment of Pain. He also recommends the book "Responsible Opioid Prescribing: A Physician’s Guide," by pain expert Dr. Scott M. Fishman (Waterford, Mich.: Waterford Life Sciences, 2007). This book incorporates the tenets set out in the FSMB’s model policy. "The basic tenet of this model is that pain management is a moral imperative; we should all be aware of the problems of pain management and the use of opioids may be necessary for our patients in pain," Dr. Mackey said.

The model also emphasizes that the use of opioids other than for a legitimate medical purpose "does pose a problem, that we have a responsibility to minimize the abuse and diversion with risk mitigation, [and] that physicians may deviate from recommended treatment when they have good cause. That means we’re not trying to box people in to rigid policies."

His recommended strategy for prescribing opioids in patients with a history of substance abuse starts with a careful assessment and formation of an appropriate differential diagnosis and a psychological assessment, including risk of addictive disorders. Next, have patients sign an informed consent for opioid treatment. "Our consent form has changed somewhat," Dr. Mackey said. "I’m giving patients more information about the potential for organ toxicity and the endocrine abnormalities that can occur as a consequence of opioid use, such as depression of sex hormones."

This is followed by asking patients to sign an opioid treatment agreement that informs them about your standard opioid prescribing policy, such as stating that medication will be refilled during regular office hours, Mondays through Fridays, that lost narcotic medication cannot be replaced, and that stolen narcotic medication may be replaced provided they obtain a police report and are seen in the office.

Dr. Mackey then begins patients on an appropriate trial of opioid therapy with or without adjunctive medications.

"I use the word ‘trial’ because people often think this is meant to be a long-term use of these medications when we try to make it clear right up front that use is for the short term," he explained. "I then assess and reassess their level of pain and function."

He also recommends that clinicians follow the "four As" for ongoing monitoring of pain treatment outcomes, a system developed by Steven D. Passik, Ph.D. These are analgesia (pain relief), activities of daily living (psychosocial functioning), adverse events (side effects), and aberrant drug taking (addiction-related outcomes).

"If you focus on those four As and document them, you can usually stay out of trouble when prescribing these medications," Dr. Mackey said. "Document everything in the medical record, because 95% of the problems that doctors run into with their state medical board have to do with failure to appropriately document."

Other efforts to mitigate risk include using predictive tools, urine drug testing when appropriate, and using your state’s prescription monitoring program. "Use family and friends and others to gather information to make sure that the patient is using the medication appropriately," he advised.

Potential signs of abuse and diversion include patients "who show up at the end of office hours and arrive without an appointment, or who often arrive right when your staff is trying to leave for the day," Dr. Mackey said. "They’re typically reluctant to have a thorough physical exam and don’t give you past medical records, they don’t follow up with appointments, and they have very unusual stories."

Dr. Mackey disclosed that he has received research funding from the National Institutes of Health, the Dodie and John Rosekrans Pain Research Endowment, and the Redlich Pain Research Endowment.

LAS VEGAS – Even the most careful clinical pain management cannot eliminate the risk of opioid misuse in patients with a history of addiction, but good communication can help reduce the risk significantly, Dr. Sean Mackey said during a psychopharmacology conference sponsored by the Nevada Psychiatric Association.

"Some of the basic tenets of managing patients with chronic opioids are education, education, and education," said Dr. Mackey, chief of the pain management division at Stanford (Calif.) University. "It’s important to set expectations for people with chronic pain. The cure is not the goal; we’re there to help improve quality of life and get people back in control of their lives, better manage pain, and improve physical functioning."

According to best estimates from existing medical literature, the prevalence of comorbid chronic pain and opioid addiction in the United States ranges between 0.6-1.2 million people, mainly affecting young adults and the elderly. But that estimate might be conservative. A June 2011 report from the Institute of Medicine noted that chronic pain affects 116 million Americans – more than the total affected by heart disease, cancer and diabetes combined – at a cost of $560-$630 billion per year. Chronic pain "is the No. 1 reason people are out of work, hitting people often at their most productive ages, and also hitting people more and more as we advance in years," Dr. Mackey said.

In his opinion, optimal management of patients with chronic pain consists of a multidisciplinary approach "in which we bring together specialists who take care of pharmacologic aspects to pain management, physical and occupational therapy approaches, psychological/behavioral approaches, and complementary and alternative medicine approaches. It’s a team-based approach. A lot of this is dealing with body education: helping people understand what is safe for them to do and what is not safe for them to do, alleviating their fears about their body.

"We do procedural approaches as well, everything from simple trigger-point injections to spinal cord stimulation – all in the context of a functional rehabilitation approach."

Psychological approaches include giving patients time-contingent dosing of medications, "on-the-clock rather than when they are experiencing pain," said Dr. Mackey, who also directs the Stanford Systems Neuroscience and Pain Lab. "We also give positive reinforcement for healthy behaviors, negative reinforcement for unhealthy behaviors, and we get their spouse involved, because their involvement is crucial to success."

To responsibly prescribe opioids, Dr. Mackey recommends that physicians become familiar with the Federation of State Medical Boards’ Model Policy for the Treatment of Pain. He also recommends the book "Responsible Opioid Prescribing: A Physician’s Guide," by pain expert Dr. Scott M. Fishman (Waterford, Mich.: Waterford Life Sciences, 2007). This book incorporates the tenets set out in the FSMB’s model policy. "The basic tenet of this model is that pain management is a moral imperative; we should all be aware of the problems of pain management and the use of opioids may be necessary for our patients in pain," Dr. Mackey said.

The model also emphasizes that the use of opioids other than for a legitimate medical purpose "does pose a problem, that we have a responsibility to minimize the abuse and diversion with risk mitigation, [and] that physicians may deviate from recommended treatment when they have good cause. That means we’re not trying to box people in to rigid policies."

His recommended strategy for prescribing opioids in patients with a history of substance abuse starts with a careful assessment and formation of an appropriate differential diagnosis and a psychological assessment, including risk of addictive disorders. Next, have patients sign an informed consent for opioid treatment. "Our consent form has changed somewhat," Dr. Mackey said. "I’m giving patients more information about the potential for organ toxicity and the endocrine abnormalities that can occur as a consequence of opioid use, such as depression of sex hormones."

This is followed by asking patients to sign an opioid treatment agreement that informs them about your standard opioid prescribing policy, such as stating that medication will be refilled during regular office hours, Mondays through Fridays, that lost narcotic medication cannot be replaced, and that stolen narcotic medication may be replaced provided they obtain a police report and are seen in the office.

Dr. Mackey then begins patients on an appropriate trial of opioid therapy with or without adjunctive medications.

"I use the word ‘trial’ because people often think this is meant to be a long-term use of these medications when we try to make it clear right up front that use is for the short term," he explained. "I then assess and reassess their level of pain and function."

He also recommends that clinicians follow the "four As" for ongoing monitoring of pain treatment outcomes, a system developed by Steven D. Passik, Ph.D. These are analgesia (pain relief), activities of daily living (psychosocial functioning), adverse events (side effects), and aberrant drug taking (addiction-related outcomes).

"If you focus on those four As and document them, you can usually stay out of trouble when prescribing these medications," Dr. Mackey said. "Document everything in the medical record, because 95% of the problems that doctors run into with their state medical board have to do with failure to appropriately document."

Other efforts to mitigate risk include using predictive tools, urine drug testing when appropriate, and using your state’s prescription monitoring program. "Use family and friends and others to gather information to make sure that the patient is using the medication appropriately," he advised.

Potential signs of abuse and diversion include patients "who show up at the end of office hours and arrive without an appointment, or who often arrive right when your staff is trying to leave for the day," Dr. Mackey said. "They’re typically reluctant to have a thorough physical exam and don’t give you past medical records, they don’t follow up with appointments, and they have very unusual stories."

Dr. Mackey disclosed that he has received research funding from the National Institutes of Health, the Dodie and John Rosekrans Pain Research Endowment, and the Redlich Pain Research Endowment.

SILVER SPRING, MD. – The clinical development of antinerve growth factors as a treatment for pain should continue, despite reports of serious joint-related adverse effects associated with these agents in clinical trials, a Food and Drug Administration panel unanimously agreed on March 12.

At the meeting, the FDA’s Arthritis Advisory Committee voted 21-0 that there was a role for the ongoing development of antinerve growth factors (anti-NGF), which panelists agreed appeared to show promise as analgesics in studies and may eventually have a niche in the treatment of chronic pain conditions. But they strongly recommended that future studies should closely monitor patients for rapidly progressing osteoarthritis (OA) and other joint-related adverse events that have been observed in trials, and include a rigorous informed-consent process so that patients are well informed about the potential risks. The panel also recommended that the manufacturers of these products conduct studies to investigate the mechanism behind the joint-related adverse events, and that in clinical trials, the use of concomitant NSAIDs should be contraindicated or limited.

The FDA convened the panel to discuss reports of joint destruction in patients treated with two of the three agents in clinical development, which resulted in a hold on clinical trials of all three agents, tanezumab (Pfizer), fulranumab (Janssen), and REGN475 (Regeneron). Anti-NGF agents, monoclonal antibodies directed against nerve growth factor, are being studied for chronic pain caused by various conditions, primarily osteoarthritis. The greatest amounts of data are available on tanezumab, which was being studied in phase III trials of patients with OA and chronic low back pain.

The FDA put a hold on clinical trials of the three anti-NGF factors in 2010, after cases of osteonecrosis and avascular necrosis were reported in osteoarthritis patients treated with tanezumab and in those treated with fulranumab, because of concerns that these cases might be a class effect. There were no such cases among patients on placebo or comparator drugs. The risk increased further among those on an NSAID and an anti-NGF agent, compared with the anti-NGF agent alone.

Panelists agreed with the FDA reviewers that that these cases were unusual and severe.

In addition to OA, the companies are developing these agents for other chronic pain conditions, including low back pain, postherpetic neuralgia, chronic pancreatitis, endometriosis, and cancer pain.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

SILVER SPRING, MD. – The clinical development of antinerve growth factors as a treatment for pain should continue, despite reports of serious joint-related adverse effects associated with these agents in clinical trials, a Food and Drug Administration panel unanimously agreed on March 12.

At the meeting, the FDA’s Arthritis Advisory Committee voted 21-0 that there was a role for the ongoing development of antinerve growth factors (anti-NGF), which panelists agreed appeared to show promise as analgesics in studies and may eventually have a niche in the treatment of chronic pain conditions. But they strongly recommended that future studies should closely monitor patients for rapidly progressing osteoarthritis (OA) and other joint-related adverse events that have been observed in trials, and include a rigorous informed-consent process so that patients are well informed about the potential risks. The panel also recommended that the manufacturers of these products conduct studies to investigate the mechanism behind the joint-related adverse events, and that in clinical trials, the use of concomitant NSAIDs should be contraindicated or limited.

The FDA convened the panel to discuss reports of joint destruction in patients treated with two of the three agents in clinical development, which resulted in a hold on clinical trials of all three agents, tanezumab (Pfizer), fulranumab (Janssen), and REGN475 (Regeneron). Anti-NGF agents, monoclonal antibodies directed against nerve growth factor, are being studied for chronic pain caused by various conditions, primarily osteoarthritis. The greatest amounts of data are available on tanezumab, which was being studied in phase III trials of patients with OA and chronic low back pain.

The FDA put a hold on clinical trials of the three anti-NGF factors in 2010, after cases of osteonecrosis and avascular necrosis were reported in osteoarthritis patients treated with tanezumab and in those treated with fulranumab, because of concerns that these cases might be a class effect. There were no such cases among patients on placebo or comparator drugs. The risk increased further among those on an NSAID and an anti-NGF agent, compared with the anti-NGF agent alone.

Panelists agreed with the FDA reviewers that that these cases were unusual and severe.

In addition to OA, the companies are developing these agents for other chronic pain conditions, including low back pain, postherpetic neuralgia, chronic pancreatitis, endometriosis, and cancer pain.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

SILVER SPRING, MD. – The clinical development of antinerve growth factors as a treatment for pain should continue, despite reports of serious joint-related adverse effects associated with these agents in clinical trials, a Food and Drug Administration panel unanimously agreed on March 12.

At the meeting, the FDA’s Arthritis Advisory Committee voted 21-0 that there was a role for the ongoing development of antinerve growth factors (anti-NGF), which panelists agreed appeared to show promise as analgesics in studies and may eventually have a niche in the treatment of chronic pain conditions. But they strongly recommended that future studies should closely monitor patients for rapidly progressing osteoarthritis (OA) and other joint-related adverse events that have been observed in trials, and include a rigorous informed-consent process so that patients are well informed about the potential risks. The panel also recommended that the manufacturers of these products conduct studies to investigate the mechanism behind the joint-related adverse events, and that in clinical trials, the use of concomitant NSAIDs should be contraindicated or limited.

The FDA convened the panel to discuss reports of joint destruction in patients treated with two of the three agents in clinical development, which resulted in a hold on clinical trials of all three agents, tanezumab (Pfizer), fulranumab (Janssen), and REGN475 (Regeneron). Anti-NGF agents, monoclonal antibodies directed against nerve growth factor, are being studied for chronic pain caused by various conditions, primarily osteoarthritis. The greatest amounts of data are available on tanezumab, which was being studied in phase III trials of patients with OA and chronic low back pain.

The FDA put a hold on clinical trials of the three anti-NGF factors in 2010, after cases of osteonecrosis and avascular necrosis were reported in osteoarthritis patients treated with tanezumab and in those treated with fulranumab, because of concerns that these cases might be a class effect. There were no such cases among patients on placebo or comparator drugs. The risk increased further among those on an NSAID and an anti-NGF agent, compared with the anti-NGF agent alone.

Panelists agreed with the FDA reviewers that that these cases were unusual and severe.

In addition to OA, the companies are developing these agents for other chronic pain conditions, including low back pain, postherpetic neuralgia, chronic pancreatitis, endometriosis, and cancer pain.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. Occasionally, a panelist may be given a waiver, but not at this meeting.

Valgus knee braces used in conjunction with specialized footwear reduced pain from medial tibiofemoral osteoarthritis by about 20% in a 30-week controlled trial, perhaps the most rigorous investigation of realignment treatment for knee osteoarthritis to date.

In a trial of randomized crossover design, 80 patients either wore a valgus knee brace (Oadjuster) plus customized neutral foot orthoses and motion-control shoes or a neutral knee brace (Montana) plus flat, nonsupportive foot orthoses and flexible mid-sole shoes for 12 weeks. They next went without treatment for 6 weeks, and then were crossed over to the alternative treatment for another 12 weeks.

Scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale were a mean of 1.82 units (95% confidence interval, –3.05 to –0.60; P value less than .004) lower when patients wore the valgus brace instead of the neutral brace. Overall, use of the valgus brace and orthoses reduced their pain by 20% from its baseline level. WOMAC function scores were 2.90 units lower (95% CI, –6.60 to 0.79) as well, but the finding was not significant (P value .12).

"We have demonstrated that the application of realignment treatment ... leads to a statistically significant improvement in knee pain compared to a placebo intervention," concluded lead author and rheumatologist Dr. David Hunter, professor of medicine at the University of Sydney and his colleagues at the New England Baptist Hospital in Boston (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200728]).

It’s not the first time valgus unloader braces have been shown to help medial knee osteoarthritis (OA). However, brace adherence and lack of adequate control treatments may have skewed findings from previous trials. There was a "need for an appropriately powered and well-controlled trial on the effect of valgus knee bracing on persons with medial knee OA. We were adequately powered to detect a clinically meaningful treatment effect," the researchers noted.

On average, patients wore their braces for more than 3 hours each day. Their mean age was 62 years, and mean body mass index 34 kg/m²; most were women. Patients were ambulatory without assistance but on most days had knee pain, aching, or stiffness. Their baseline pain score was 9.2 on the 20-point WOMAC scale. Radiographs confirmed osteophytes and predominantly medial tibiofemoral OA.

Patients in the trial were new to prescription knee braces and customized orthotics. To help control for the placebo effect – strong in OA trials – they weren’t told that the valgus brace was the active treatment.

Despite better pain control, however, the active treatment was more problematic. Sixteen patients had a hard time keeping the valgus brace in place, a problem for only four with the neutral brace. Seven patients said the motion-control shoes were painful. Just one said the flexible midsole control shoes hurt.

The researchers included the shoes and inserts because "even with appropriate valgus bracing, large mechanical stresses on the knee can persist, suggesting that the addition of other interventions to further improve limb alignment may be of therapeutic value," they noted.

In all, 24 patients (30%) dropped out of the study. Some were lost to follow-up, while others scheduled joint replacements or didn’t comply with treatment. An intent-to-treat analysis was used to reduce the impact.

DonJoy supplied the braces, and New Balance supplied the shoes and inserts. The companies otherwise were uninvolved in the project, which was funded by the National Institute on Disability and Rehabilitation Research. The researchers reported no relevant financial conflicts of interest.

Valgus knee braces used in conjunction with specialized footwear reduced pain from medial tibiofemoral osteoarthritis by about 20% in a 30-week controlled trial, perhaps the most rigorous investigation of realignment treatment for knee osteoarthritis to date.

In a trial of randomized crossover design, 80 patients either wore a valgus knee brace (Oadjuster) plus customized neutral foot orthoses and motion-control shoes or a neutral knee brace (Montana) plus flat, nonsupportive foot orthoses and flexible mid-sole shoes for 12 weeks. They next went without treatment for 6 weeks, and then were crossed over to the alternative treatment for another 12 weeks.

Scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale were a mean of 1.82 units (95% confidence interval, –3.05 to –0.60; P value less than .004) lower when patients wore the valgus brace instead of the neutral brace. Overall, use of the valgus brace and orthoses reduced their pain by 20% from its baseline level. WOMAC function scores were 2.90 units lower (95% CI, –6.60 to 0.79) as well, but the finding was not significant (P value .12).

"We have demonstrated that the application of realignment treatment ... leads to a statistically significant improvement in knee pain compared to a placebo intervention," concluded lead author and rheumatologist Dr. David Hunter, professor of medicine at the University of Sydney and his colleagues at the New England Baptist Hospital in Boston (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200728]).

It’s not the first time valgus unloader braces have been shown to help medial knee osteoarthritis (OA). However, brace adherence and lack of adequate control treatments may have skewed findings from previous trials. There was a "need for an appropriately powered and well-controlled trial on the effect of valgus knee bracing on persons with medial knee OA. We were adequately powered to detect a clinically meaningful treatment effect," the researchers noted.

On average, patients wore their braces for more than 3 hours each day. Their mean age was 62 years, and mean body mass index 34 kg/m²; most were women. Patients were ambulatory without assistance but on most days had knee pain, aching, or stiffness. Their baseline pain score was 9.2 on the 20-point WOMAC scale. Radiographs confirmed osteophytes and predominantly medial tibiofemoral OA.

Patients in the trial were new to prescription knee braces and customized orthotics. To help control for the placebo effect – strong in OA trials – they weren’t told that the valgus brace was the active treatment.

Despite better pain control, however, the active treatment was more problematic. Sixteen patients had a hard time keeping the valgus brace in place, a problem for only four with the neutral brace. Seven patients said the motion-control shoes were painful. Just one said the flexible midsole control shoes hurt.

The researchers included the shoes and inserts because "even with appropriate valgus bracing, large mechanical stresses on the knee can persist, suggesting that the addition of other interventions to further improve limb alignment may be of therapeutic value," they noted.

In all, 24 patients (30%) dropped out of the study. Some were lost to follow-up, while others scheduled joint replacements or didn’t comply with treatment. An intent-to-treat analysis was used to reduce the impact.

DonJoy supplied the braces, and New Balance supplied the shoes and inserts. The companies otherwise were uninvolved in the project, which was funded by the National Institute on Disability and Rehabilitation Research. The researchers reported no relevant financial conflicts of interest.

Valgus knee braces used in conjunction with specialized footwear reduced pain from medial tibiofemoral osteoarthritis by about 20% in a 30-week controlled trial, perhaps the most rigorous investigation of realignment treatment for knee osteoarthritis to date.

In a trial of randomized crossover design, 80 patients either wore a valgus knee brace (Oadjuster) plus customized neutral foot orthoses and motion-control shoes or a neutral knee brace (Montana) plus flat, nonsupportive foot orthoses and flexible mid-sole shoes for 12 weeks. They next went without treatment for 6 weeks, and then were crossed over to the alternative treatment for another 12 weeks.

Scores on the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain scale were a mean of 1.82 units (95% confidence interval, –3.05 to –0.60; P value less than .004) lower when patients wore the valgus brace instead of the neutral brace. Overall, use of the valgus brace and orthoses reduced their pain by 20% from its baseline level. WOMAC function scores were 2.90 units lower (95% CI, –6.60 to 0.79) as well, but the finding was not significant (P value .12).

"We have demonstrated that the application of realignment treatment ... leads to a statistically significant improvement in knee pain compared to a placebo intervention," concluded lead author and rheumatologist Dr. David Hunter, professor of medicine at the University of Sydney and his colleagues at the New England Baptist Hospital in Boston (Ann. Rheum. Dis. 2012 Feb. 29 [doi: 10.1136/annrheumdis-2011-200728]).

It’s not the first time valgus unloader braces have been shown to help medial knee osteoarthritis (OA). However, brace adherence and lack of adequate control treatments may have skewed findings from previous trials. There was a "need for an appropriately powered and well-controlled trial on the effect of valgus knee bracing on persons with medial knee OA. We were adequately powered to detect a clinically meaningful treatment effect," the researchers noted.

On average, patients wore their braces for more than 3 hours each day. Their mean age was 62 years, and mean body mass index 34 kg/m²; most were women. Patients were ambulatory without assistance but on most days had knee pain, aching, or stiffness. Their baseline pain score was 9.2 on the 20-point WOMAC scale. Radiographs confirmed osteophytes and predominantly medial tibiofemoral OA.

Patients in the trial were new to prescription knee braces and customized orthotics. To help control for the placebo effect – strong in OA trials – they weren’t told that the valgus brace was the active treatment.

Despite better pain control, however, the active treatment was more problematic. Sixteen patients had a hard time keeping the valgus brace in place, a problem for only four with the neutral brace. Seven patients said the motion-control shoes were painful. Just one said the flexible midsole control shoes hurt.

The researchers included the shoes and inserts because "even with appropriate valgus bracing, large mechanical stresses on the knee can persist, suggesting that the addition of other interventions to further improve limb alignment may be of therapeutic value," they noted.

In all, 24 patients (30%) dropped out of the study. Some were lost to follow-up, while others scheduled joint replacements or didn’t comply with treatment. An intent-to-treat analysis was used to reduce the impact.

DonJoy supplied the braces, and New Balance supplied the shoes and inserts. The companies otherwise were uninvolved in the project, which was funded by the National Institute on Disability and Rehabilitation Research. The researchers reported no relevant financial conflicts of interest.

PALM SPRINGS, CALIF. – Off-label use of daily low-dose naltrexone hydrochloride reduced fibromyalgia pain severity by an average of 48%, compared with a 27% pain reduction on placebo in a double-blind crossover trial in 28 women.

"These are statistically significant results, and I think they are also clinically significant," said Jarred Younger, Ph.D., at the annual meeting of the American Academy of Pain Medicine.

Tolerability ratings of a regimen of 4.5 mg daily of naltrexone and placebo were statistically equivalent, with scores of 89 (of a possible 100, which represented perfectly tolerated treatment) for both naltrexone and placebo. Side effects associated with use of naltrexone were mild and transient, with significantly more patients reporting vivid dreams (37%) and headaches (16%) on the drug compared with placebo (13% and 3%, respectively).

Low-dose naltrexone, an opioid agonist, is not approved by the Food and Drug Administration and must be custom compounded, but the drug is generic and costs less than $40 per month, said Dr. Younger, director of the adult and pediatric pain laboratory at Stanford (Calif.) University.

"We know it’s cheap, and we know it’s easy to get ahold of," he said.

The 22-week study included women aged 23-65 years living near Stanford who fulfilled the American College of Rheumatology’s 1990 criteria for fibromyalgia, including having 11 of 18 tender points. They had had fibromyalgia for a mean of 12 years. Patients were allowed to continue taking their medications as normal, with the exclusion of opioid analgesics.

After a 2-week run-in period, patients were randomized to either 12 weeks of naltrexone or 4 weeks of placebo, taken daily with or without food or water approximately 1 hour before bedtime, in the form of an opaque gelatin capsule with microcrystalline cellulose filler and noncaloric sweetener. The treatment groups then switched to the other regimen for a total of 16 weeks of treatment or placebo, ending with a 4-week follow-up period.

Patients daily rated their pain, fatigue, and other symptoms on a handheld computer; they were assessed every 2 weeks in the laboratory for side effects and were given a new bottle of capsules. Investigators calculated the mean reduction in symptom severity based on measurements in the final 3 days on the drug or placebo.

Three other patients (for a total of 31) were randomized in the study but were excluded from the final analysis, two of them because they stopped taking the capsules.

"Global impression of change" ratings by 30 patients showed that after 12 weeks on naltrexone, 13% reported that their pain was very much improved, 37% said it was much improved, 20% reported minimal improvement, 20% said there was no change in pain, and 10% said pain was minimally worse.

By the end of the naltrexone phase, 57% of patients reported a 30% or greater reduction in pain, Dr. Younger and his associates reported.

Fatigue and sleep quality were not significantly improved on naltrexone, compared with placebo. Patients were not able to guess accurately whether they were receiving the drug or placebo.

The findings confirm results of a 10-patient pilot study by the same investigators (Pain Med. 2009;10:663-72). "We now have two studies" suggesting that low-dose naltrexone reduces the severity of fibromyalgia pain, he said.

Low-dose naltrexone deserves a larger, parallel-group, randomized, controlled trial to further confirm the results in a larger cohort, he added.

Naltrexone is microglia moderator, and the investigators hypothesized that this may be the mechanism of action in reducing fibromyalgia pain. Abnormal functioning of microglia may cause the central sensitivity seen in fibromyalgia and the subsequent overproduction of proinflammatory factors. In-vitro and animal studies have shown that naltrexone reduces microglia hyperexcitability, suppressing the production of proinflammatory cytokines, reducing pain, and serving a neuroprotective function, he said.

Dr. Younger said that future studies also should assess other potential microglia modulators, including ibudilast and 3-hydroxymorphinan. Fluorocitrate, minocycline, and dextromethorphan also are microglia modulators.

A physician in the audience noted that the current study showed a higher-than-usual placebo effect, and wondered about the cause. "I wondered about that very thing," Dr. Younger replied. The previous pilot study found a lower placebo effect, but the results of the pilot study became widely known and may have increased expectations and the effect of placebo in the women who were recruited to the current study, he speculated.

The study excluded women with abnormal or elevated levels of rheumatoid factor, antinuclear antibodies, erythrocyte sedimentation rate, or C-reactive protein; women who were taking opioid analgesics; and women with joint inflammation or a history of autoimmune disease.

Approximately 5% of U.S. women and 2% of men are thought to have fibromyalgia.

Dr. Younger reported having no financial disclosures. Funding for the study came primarily from the American Fibromyalgia Syndrome Association, with other support from Jim and Connie Binns, the Oxnard Foundation, the Chris Redlich Pain Research Endowment, and the Rosekran Pain Research Endowment.

PALM SPRINGS, CALIF. – Off-label use of daily low-dose naltrexone hydrochloride reduced fibromyalgia pain severity by an average of 48%, compared with a 27% pain reduction on placebo in a double-blind crossover trial in 28 women.

"These are statistically significant results, and I think they are also clinically significant," said Jarred Younger, Ph.D., at the annual meeting of the American Academy of Pain Medicine.

Tolerability ratings of a regimen of 4.5 mg daily of naltrexone and placebo were statistically equivalent, with scores of 89 (of a possible 100, which represented perfectly tolerated treatment) for both naltrexone and placebo. Side effects associated with use of naltrexone were mild and transient, with significantly more patients reporting vivid dreams (37%) and headaches (16%) on the drug compared with placebo (13% and 3%, respectively).

Low-dose naltrexone, an opioid agonist, is not approved by the Food and Drug Administration and must be custom compounded, but the drug is generic and costs less than $40 per month, said Dr. Younger, director of the adult and pediatric pain laboratory at Stanford (Calif.) University.

"We know it’s cheap, and we know it’s easy to get ahold of," he said.

The 22-week study included women aged 23-65 years living near Stanford who fulfilled the American College of Rheumatology’s 1990 criteria for fibromyalgia, including having 11 of 18 tender points. They had had fibromyalgia for a mean of 12 years. Patients were allowed to continue taking their medications as normal, with the exclusion of opioid analgesics.

After a 2-week run-in period, patients were randomized to either 12 weeks of naltrexone or 4 weeks of placebo, taken daily with or without food or water approximately 1 hour before bedtime, in the form of an opaque gelatin capsule with microcrystalline cellulose filler and noncaloric sweetener. The treatment groups then switched to the other regimen for a total of 16 weeks of treatment or placebo, ending with a 4-week follow-up period.

Patients daily rated their pain, fatigue, and other symptoms on a handheld computer; they were assessed every 2 weeks in the laboratory for side effects and were given a new bottle of capsules. Investigators calculated the mean reduction in symptom severity based on measurements in the final 3 days on the drug or placebo.

Three other patients (for a total of 31) were randomized in the study but were excluded from the final analysis, two of them because they stopped taking the capsules.

"Global impression of change" ratings by 30 patients showed that after 12 weeks on naltrexone, 13% reported that their pain was very much improved, 37% said it was much improved, 20% reported minimal improvement, 20% said there was no change in pain, and 10% said pain was minimally worse.

By the end of the naltrexone phase, 57% of patients reported a 30% or greater reduction in pain, Dr. Younger and his associates reported.

Fatigue and sleep quality were not significantly improved on naltrexone, compared with placebo. Patients were not able to guess accurately whether they were receiving the drug or placebo.

The findings confirm results of a 10-patient pilot study by the same investigators (Pain Med. 2009;10:663-72). "We now have two studies" suggesting that low-dose naltrexone reduces the severity of fibromyalgia pain, he said.

Low-dose naltrexone deserves a larger, parallel-group, randomized, controlled trial to further confirm the results in a larger cohort, he added.

Naltrexone is microglia moderator, and the investigators hypothesized that this may be the mechanism of action in reducing fibromyalgia pain. Abnormal functioning of microglia may cause the central sensitivity seen in fibromyalgia and the subsequent overproduction of proinflammatory factors. In-vitro and animal studies have shown that naltrexone reduces microglia hyperexcitability, suppressing the production of proinflammatory cytokines, reducing pain, and serving a neuroprotective function, he said.

Dr. Younger said that future studies also should assess other potential microglia modulators, including ibudilast and 3-hydroxymorphinan. Fluorocitrate, minocycline, and dextromethorphan also are microglia modulators.

A physician in the audience noted that the current study showed a higher-than-usual placebo effect, and wondered about the cause. "I wondered about that very thing," Dr. Younger replied. The previous pilot study found a lower placebo effect, but the results of the pilot study became widely known and may have increased expectations and the effect of placebo in the women who were recruited to the current study, he speculated.

The study excluded women with abnormal or elevated levels of rheumatoid factor, antinuclear antibodies, erythrocyte sedimentation rate, or C-reactive protein; women who were taking opioid analgesics; and women with joint inflammation or a history of autoimmune disease.

Approximately 5% of U.S. women and 2% of men are thought to have fibromyalgia.

Dr. Younger reported having no financial disclosures. Funding for the study came primarily from the American Fibromyalgia Syndrome Association, with other support from Jim and Connie Binns, the Oxnard Foundation, the Chris Redlich Pain Research Endowment, and the Rosekran Pain Research Endowment.

PALM SPRINGS, CALIF. – Off-label use of daily low-dose naltrexone hydrochloride reduced fibromyalgia pain severity by an average of 48%, compared with a 27% pain reduction on placebo in a double-blind crossover trial in 28 women.

"These are statistically significant results, and I think they are also clinically significant," said Jarred Younger, Ph.D., at the annual meeting of the American Academy of Pain Medicine.

Tolerability ratings of a regimen of 4.5 mg daily of naltrexone and placebo were statistically equivalent, with scores of 89 (of a possible 100, which represented perfectly tolerated treatment) for both naltrexone and placebo. Side effects associated with use of naltrexone were mild and transient, with significantly more patients reporting vivid dreams (37%) and headaches (16%) on the drug compared with placebo (13% and 3%, respectively).

Low-dose naltrexone, an opioid agonist, is not approved by the Food and Drug Administration and must be custom compounded, but the drug is generic and costs less than $40 per month, said Dr. Younger, director of the adult and pediatric pain laboratory at Stanford (Calif.) University.

"We know it’s cheap, and we know it’s easy to get ahold of," he said.

The 22-week study included women aged 23-65 years living near Stanford who fulfilled the American College of Rheumatology’s 1990 criteria for fibromyalgia, including having 11 of 18 tender points. They had had fibromyalgia for a mean of 12 years. Patients were allowed to continue taking their medications as normal, with the exclusion of opioid analgesics.

After a 2-week run-in period, patients were randomized to either 12 weeks of naltrexone or 4 weeks of placebo, taken daily with or without food or water approximately 1 hour before bedtime, in the form of an opaque gelatin capsule with microcrystalline cellulose filler and noncaloric sweetener. The treatment groups then switched to the other regimen for a total of 16 weeks of treatment or placebo, ending with a 4-week follow-up period.

Patients daily rated their pain, fatigue, and other symptoms on a handheld computer; they were assessed every 2 weeks in the laboratory for side effects and were given a new bottle of capsules. Investigators calculated the mean reduction in symptom severity based on measurements in the final 3 days on the drug or placebo.

Three other patients (for a total of 31) were randomized in the study but were excluded from the final analysis, two of them because they stopped taking the capsules.

"Global impression of change" ratings by 30 patients showed that after 12 weeks on naltrexone, 13% reported that their pain was very much improved, 37% said it was much improved, 20% reported minimal improvement, 20% said there was no change in pain, and 10% said pain was minimally worse.

By the end of the naltrexone phase, 57% of patients reported a 30% or greater reduction in pain, Dr. Younger and his associates reported.

Fatigue and sleep quality were not significantly improved on naltrexone, compared with placebo. Patients were not able to guess accurately whether they were receiving the drug or placebo.

The findings confirm results of a 10-patient pilot study by the same investigators (Pain Med. 2009;10:663-72). "We now have two studies" suggesting that low-dose naltrexone reduces the severity of fibromyalgia pain, he said.

Low-dose naltrexone deserves a larger, parallel-group, randomized, controlled trial to further confirm the results in a larger cohort, he added.

Naltrexone is microglia moderator, and the investigators hypothesized that this may be the mechanism of action in reducing fibromyalgia pain. Abnormal functioning of microglia may cause the central sensitivity seen in fibromyalgia and the subsequent overproduction of proinflammatory factors. In-vitro and animal studies have shown that naltrexone reduces microglia hyperexcitability, suppressing the production of proinflammatory cytokines, reducing pain, and serving a neuroprotective function, he said.

Dr. Younger said that future studies also should assess other potential microglia modulators, including ibudilast and 3-hydroxymorphinan. Fluorocitrate, minocycline, and dextromethorphan also are microglia modulators.

A physician in the audience noted that the current study showed a higher-than-usual placebo effect, and wondered about the cause. "I wondered about that very thing," Dr. Younger replied. The previous pilot study found a lower placebo effect, but the results of the pilot study became widely known and may have increased expectations and the effect of placebo in the women who were recruited to the current study, he speculated.

The study excluded women with abnormal or elevated levels of rheumatoid factor, antinuclear antibodies, erythrocyte sedimentation rate, or C-reactive protein; women who were taking opioid analgesics; and women with joint inflammation or a history of autoimmune disease.

Approximately 5% of U.S. women and 2% of men are thought to have fibromyalgia.

Dr. Younger reported having no financial disclosures. Funding for the study came primarily from the American Fibromyalgia Syndrome Association, with other support from Jim and Connie Binns, the Oxnard Foundation, the Chris Redlich Pain Research Endowment, and the Rosekran Pain Research Endowment.

An immediate access clinic significantly reduced the wait times for patients seeking rheumatology assessments, based on data from 660 patients seen between February and December 2009. The findings were published in the March issue of Annals of the Rheumatic Diseases.

"The delay from symptom onset to the first visit with a rheumatologist or start of therapy ranges from several months up to more than 1 year," said Dr. Miriam Gärtner of the Medical University of Vienna and her colleagues.

One reason for the delay in care is the lack of rheumatologists, the researchers said. To help get patients started on therapy sooner, an immediate access clinic (IAC) was established, in which patients could be seen within 1 day to 2 weeks of their referral, or seen immediately for a brief evaluation without a referral.

Of 1,036 patients who were assessed in the clinic during the study period, 660 patients were reevaluated 6-12 months after visiting the clinic. The patients were divided into those who were referred for further care in the clinic (331 patients) and those referred for further care outside of the clinic (329 patients). The average age of the patients was 50 years, and the average duration of symptoms was 24 years; the average pain rating on the visual analog scale of 0-100 mm was 54 mm (Ann. Rheum. Dis. 2012;71:363-8).

At a 6- to 12-month follow-up visit, 75% of the initial diagnoses that had been made at the clinic proved to be correct, the researchers said. "This indicates high reliability of these initial categorizations by an experienced rheumatologist, which often have to be made within only a few minutes, compared with a later and mostly ‘criteria-based’ classification," they said.

Of the patients who were referred for follow-up in the clinic, 213 returned for additional care and 118 did not return. Overall, 90% of those who returned for additional care received treatment depending on their diagnoses, with 25%-73% receiving disease-modifying antirheumatic drugs, 1%-25% receiving biologics, *5%-56% receiving glucocorticoids, and 2%-17% receiving physiotherapy. Of those who did not return for additional care (but were contacted later by phone), 38% said they received additional therapy at their initial visit. Of these, 42% received NSAIDs, 16% received biologics, 13% received synthetic DMARDs or physiotherapy, and 4% received glucocorticoids.

Of the 329 who were reached for follow-up after 6-12 months, 60% reported that their medical problems were "fully resolved," whereas approximately 40% said they were receiving additional medical care.

Approximately one-third of the patients were referred to the clinic because of suspected RA, but their median symptom duration of 9 months was beyond the ideal window of opportunity for effective early treatment (which should be within the first 3 months), the researchers noted.

Men were diagnosed with spondyloarthropathy more often than women, whereas women were more often diagnosed with osteoarthritis.

Also, "no difference in the frequency of final diagnosis of an inflammatory rheumatic disease between physician and self-referred individuals was apparent," the researchers said.

The study findings were limited by the potential unreliability of telephone interviews. But the results suggest that the IAC model is effective for reducing wait times for seeing a rheumatologist, and that the majority of the diagnoses made in this setting were accurate, the researchers said.

"Despite the short time of interaction between patient and rheumatologist at the time of the visit to the IAC, complaints about insufficient attention were very rare," the researchers added. "Apparently, patients appreciated the fact that they had an immediate opportunity to discuss their problems with a specialist, albeit for a short time, and to receive an initial diagnostic assessment and therapeutic recommendations," they said.

Dr. Gärtner and colleagues had no financial conflicts to disclose.

* Correction, 3/2/2012: An earlier version of this story incorrectly reported the percentages of returning patients who received glucocorticoids.

An immediate access clinic significantly reduced the wait times for patients seeking rheumatology assessments, based on data from 660 patients seen between February and December 2009. The findings were published in the March issue of Annals of the Rheumatic Diseases.

"The delay from symptom onset to the first visit with a rheumatologist or start of therapy ranges from several months up to more than 1 year," said Dr. Miriam Gärtner of the Medical University of Vienna and her colleagues.

One reason for the delay in care is the lack of rheumatologists, the researchers said. To help get patients started on therapy sooner, an immediate access clinic (IAC) was established, in which patients could be seen within 1 day to 2 weeks of their referral, or seen immediately for a brief evaluation without a referral.

Of 1,036 patients who were assessed in the clinic during the study period, 660 patients were reevaluated 6-12 months after visiting the clinic. The patients were divided into those who were referred for further care in the clinic (331 patients) and those referred for further care outside of the clinic (329 patients). The average age of the patients was 50 years, and the average duration of symptoms was 24 years; the average pain rating on the visual analog scale of 0-100 mm was 54 mm (Ann. Rheum. Dis. 2012;71:363-8).

At a 6- to 12-month follow-up visit, 75% of the initial diagnoses that had been made at the clinic proved to be correct, the researchers said. "This indicates high reliability of these initial categorizations by an experienced rheumatologist, which often have to be made within only a few minutes, compared with a later and mostly ‘criteria-based’ classification," they said.

Of the patients who were referred for follow-up in the clinic, 213 returned for additional care and 118 did not return. Overall, 90% of those who returned for additional care received treatment depending on their diagnoses, with 25%-73% receiving disease-modifying antirheumatic drugs, 1%-25% receiving biologics, *5%-56% receiving glucocorticoids, and 2%-17% receiving physiotherapy. Of those who did not return for additional care (but were contacted later by phone), 38% said they received additional therapy at their initial visit. Of these, 42% received NSAIDs, 16% received biologics, 13% received synthetic DMARDs or physiotherapy, and 4% received glucocorticoids.

Of the 329 who were reached for follow-up after 6-12 months, 60% reported that their medical problems were "fully resolved," whereas approximately 40% said they were receiving additional medical care.

Approximately one-third of the patients were referred to the clinic because of suspected RA, but their median symptom duration of 9 months was beyond the ideal window of opportunity for effective early treatment (which should be within the first 3 months), the researchers noted.

Men were diagnosed with spondyloarthropathy more often than women, whereas women were more often diagnosed with osteoarthritis.

Also, "no difference in the frequency of final diagnosis of an inflammatory rheumatic disease between physician and self-referred individuals was apparent," the researchers said.

The study findings were limited by the potential unreliability of telephone interviews. But the results suggest that the IAC model is effective for reducing wait times for seeing a rheumatologist, and that the majority of the diagnoses made in this setting were accurate, the researchers said.

"Despite the short time of interaction between patient and rheumatologist at the time of the visit to the IAC, complaints about insufficient attention were very rare," the researchers added. "Apparently, patients appreciated the fact that they had an immediate opportunity to discuss their problems with a specialist, albeit for a short time, and to receive an initial diagnostic assessment and therapeutic recommendations," they said.

Dr. Gärtner and colleagues had no financial conflicts to disclose.

* Correction, 3/2/2012: An earlier version of this story incorrectly reported the percentages of returning patients who received glucocorticoids.

An immediate access clinic significantly reduced the wait times for patients seeking rheumatology assessments, based on data from 660 patients seen between February and December 2009. The findings were published in the March issue of Annals of the Rheumatic Diseases.

"The delay from symptom onset to the first visit with a rheumatologist or start of therapy ranges from several months up to more than 1 year," said Dr. Miriam Gärtner of the Medical University of Vienna and her colleagues.

One reason for the delay in care is the lack of rheumatologists, the researchers said. To help get patients started on therapy sooner, an immediate access clinic (IAC) was established, in which patients could be seen within 1 day to 2 weeks of their referral, or seen immediately for a brief evaluation without a referral.

Of 1,036 patients who were assessed in the clinic during the study period, 660 patients were reevaluated 6-12 months after visiting the clinic. The patients were divided into those who were referred for further care in the clinic (331 patients) and those referred for further care outside of the clinic (329 patients). The average age of the patients was 50 years, and the average duration of symptoms was 24 years; the average pain rating on the visual analog scale of 0-100 mm was 54 mm (Ann. Rheum. Dis. 2012;71:363-8).

At a 6- to 12-month follow-up visit, 75% of the initial diagnoses that had been made at the clinic proved to be correct, the researchers said. "This indicates high reliability of these initial categorizations by an experienced rheumatologist, which often have to be made within only a few minutes, compared with a later and mostly ‘criteria-based’ classification," they said.

Of the patients who were referred for follow-up in the clinic, 213 returned for additional care and 118 did not return. Overall, 90% of those who returned for additional care received treatment depending on their diagnoses, with 25%-73% receiving disease-modifying antirheumatic drugs, 1%-25% receiving biologics, *5%-56% receiving glucocorticoids, and 2%-17% receiving physiotherapy. Of those who did not return for additional care (but were contacted later by phone), 38% said they received additional therapy at their initial visit. Of these, 42% received NSAIDs, 16% received biologics, 13% received synthetic DMARDs or physiotherapy, and 4% received glucocorticoids.

Of the 329 who were reached for follow-up after 6-12 months, 60% reported that their medical problems were "fully resolved," whereas approximately 40% said they were receiving additional medical care.

Approximately one-third of the patients were referred to the clinic because of suspected RA, but their median symptom duration of 9 months was beyond the ideal window of opportunity for effective early treatment (which should be within the first 3 months), the researchers noted.

Men were diagnosed with spondyloarthropathy more often than women, whereas women were more often diagnosed with osteoarthritis.

Also, "no difference in the frequency of final diagnosis of an inflammatory rheumatic disease between physician and self-referred individuals was apparent," the researchers said.

The study findings were limited by the potential unreliability of telephone interviews. But the results suggest that the IAC model is effective for reducing wait times for seeing a rheumatologist, and that the majority of the diagnoses made in this setting were accurate, the researchers said.

"Despite the short time of interaction between patient and rheumatologist at the time of the visit to the IAC, complaints about insufficient attention were very rare," the researchers added. "Apparently, patients appreciated the fact that they had an immediate opportunity to discuss their problems with a specialist, albeit for a short time, and to receive an initial diagnostic assessment and therapeutic recommendations," they said.

Dr. Gärtner and colleagues had no financial conflicts to disclose.

* Correction, 3/2/2012: An earlier version of this story incorrectly reported the percentages of returning patients who received glucocorticoids.